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Attention all pharmedgrp.com Clients
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 30, 2005:
CLASS II
PRODUCT: cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275, Recall # Z-0174-06
MANUFACTURER: Haemonetics Corporation, Braintree, MA, by letter on July 22, 2005. Firm initiated recall is ongoing.
REASON: Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System.
PRODUCT: Lysus® Infusion System - PT-3 Control. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Recall # Z-0175-06
MANUFACTURER: Ekos Corporation, Bothell, WA, by visit beginning on January 19, 2005. Firm initiated recall is complete.
REASON: Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
PRODUCT: Bard RespiShield- * Closed Suction System with InnoValve- * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only, Recall # Z-0178-06
MANUFACTURER: Recalling Firm: C.R. Bard, Inc., Covington, GA, by letter on/about September 28, 2005. Manufacturer: Bard Sdn Bhd, Nogales, Mexico. Firm initiated recall is ongoing.
REASON: Varying degrees of difficulty were encountered when opening and closing the InnoValve.
PRODUCT: a) FHC microTargeting Power Assist System used with the micro
Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS; 66EL-MS-02;
66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD. Recall # Z-0179-06; b)
Medtronic microTargeting Drive Motor Option used with the micro Targeting
Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and
FHC 1008-66,
Recall # Z-0180-06
MANUFACTURER: FHC, Inc, Bowdoinham, ME, by letter on October 31, 2005. Firm initiated recall is ongoing.
REASON: Power Assist microTargeting System may advance beyond intended target
PRODUCT: Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. Recall # Z-0181-06
MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by telephone, and letter dated October 19, 2005. Firm initiated recall is ongoing.
REASON: The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
PRODUCT: AQuify- Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile, Recall # Z-0182-06
MANUFACTURER: Recalling Firm: CIBA Vision Corporation, Duluth, GA, by telephone and letter on November 4, 2005. Manufacturer: Ciba Vision Sterile Manufacturing, Ontario, Canada. Firm initiated recall is ongoing.
REASON: Lack of assurance of sterility at the time of manufacture.
PRODUCT: Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Recall # Z-0183-06
MANUFACTURER: Recalling Firm: Theken Spine LLC, Akron, OH, by letter, dated April 4, 2005. Manufacturer: Holmed Corporation, South Easton, MA. Firm initiated recall is ongoing.
REASON: The torque value of the device may increase over time. The increase could exceed the tolerance specification.
PRODUCT: a) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0184-06; b) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0185-06; c) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings. Recall # Z-0186-06
MANUFACTURER: Pulmonetic Systems, Inc., Minneapolis, MN, by letter dated November 9, 2005. Firm initiated recall is ongoing.
REASON: Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the
following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR
(models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following: SSI (model 1326); DDD
(model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I
Entra pacemakers are multiprogrammable pacemakers from Intermedics. The
family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate
models have an accelerometer, which is a motion sensor that responds to
patient activity. Sterilized with gaseous ethylene oxide. Recall #
Z-0187-06; b) Guidant INSIGNIA I Ultra family of pacemakers includes the
following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I
Ultra family of pacemakers includes the following: SR (model 1390) and DR
(model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Ultra pacemakers are
multiprogrammable pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. Two sensors are available: these adapt
the pacing rate to the patient’s changing metabolic demand. Minute
ventilation responds to changes in respiration, and the accelerometer
responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models
can use either the accelerometer or minute ventilation sensor, or a blend
of both accelerometer and minute ventilation. Sterilized with gaseous
ethylene oxide, Recall # Z-0188-06; c) Guidant INSIGNIA I Plus family of
pacemakers includes
the following: SR (models1194); and DR (models 1297, 1298). Intermedics
NEXUS I Plus family of pacemakers includes the following: SR (model 1394)
and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are
multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are
multiprogrammable pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic functionality. Two
sensors are available: these adapt the pacing rate to the patient’s
changing metabolic demand. Minute ventilation responds to changes in
respiration, and the accelerometer responds to patient activity (motion).
INSIGNIA and NEXUS I Plus models can use either the accelerometer or
Minute ventilation sensor, or a blend of both Accelerometer and minute
ventilation. Sterilized with gaseous ethylene oxide. Recall # Z-0189-06;
d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI
(model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR
(model 1292). Intermedics NEXUS I AVT family of pacemakers includes the
following: SR (model 1392). The INSIGNIA I AVT pacemakers are
multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are
multiprogrammable pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus
adaptive-rate models have an accelerometer, which is a motion sensor that
responds to patient activity. Sterilized with gaseous ethylene oxide.
Recall # Z-0190-06
MANUFACTURER: Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON: A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the
following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR
(models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following: SSI (model 1326); DDD
(model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I
Entra pacemakers are multiprogrammable pacemakers from Intermedics. The
family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate
models have an accelerometer, which is a motion sensor that responds to
patient
activity. Sterilized with gaseous ethylene oxide, Recall # Z-0191-06; b)
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR
(models1190); and DR (models 1290, 1291). Intermedics NEXUS I Ultra family
of pacemakers includes the following: SR (model 1390) and DR (model 1490,
1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers
from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists ofboth dual-chamber and
single-chamber models, offering adaptive-rate therapy and providing
various levels of therapeutic and diagnostic functionality. These
pacemakers include ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. Two sensors are available: these adapt
the pacing rate to the patient’s changing metabolic demand. Minute
ventilation responds to changes in respiration, and the accelerometer
responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models
can use either the accelerometer or minute ventilation sensor, or a blend
of both accelerometer and minute ventilation. Sterilized with gaseous
ethylene oxide. Recall # Z-0192-06; c) Guidant INSIGNIA I Plus family of
pacemakers includesthe following: SR (model 1194); and DR (models 1297,
1298). Intermedics NEXUS I Plus family of pacemakers includes the
following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus
pacemakers are multiprogrammable pacemakers from Intermedics. The family
consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. Two sensors are available: these adapt the
pacing rate to the patient's changing metabolic demand. Minute ventilation
responds to changes in respiration, and the accelerometer responds to
patient activity (motion). INSIGNIA and NEXUS I Plus models can use either
the accelerometer or minute ventilation sensor, or a blend of both
accelerometer and minute ventilation. Sterilized with gaseous ethylene
oxide,Recall # Z-0193-06; d) Guidant INSIGNIA I AVT family of pacemakers
includes the following: SSI (model 482), VDD (model 882), DDD (model 982),
SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of
pacemakers includesthe following: SR (model 1392). The INSIGNIA I AVT
pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT
pacemakers are multiprogrammable pacemakers from Intermedics. The family
consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and
diagnostic functionality. These pacemakers include ventricular Automatic
Capture which automatically measures the ventricular pacing threshold and
adjusts the pacing output to 0.5 V above the measured threshold. The
INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer,
which is a motion sensor that responds to patient activity. Sterilized
with gaseous ethylene oxide, Recall # Z-0194-05
MANUFACTURER: Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON: Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
PRODUCT: LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; list number 11235-03, Recall # Z-0195-06
MANUFACTURER: Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated May 6, 2005. Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is complete.
REASON: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
PRODUCT: Analogic SyneRad Multi Digital Radiology System, Model AN6150, Recall # Z-0196-06
MANUFACTURER: Analogic Corporation, Peabody, MA, by e-mail on October 14, 2005 and by letter on October 17, 2005. Firm initiated recall is complete.
REASON: Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possible injury of the user or patient.
PRODUCT: a) Damon 3 Bracket Upper Right lateral .022 slot This device is a fixed attachment on a tooth which Holds an archwire during orthodontic treatment. Part Number 491-4210, Recall # Z-0203-06; b) Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211, Recall # Z-0204-06
MANUFACTURER: Ormco Corporation, Glendora, CA, by telephone and letters on November 3, 2005. Firm initiated recall is ongoing.
REASON: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
PRODUCT: Self Contained Biological Indicator, product code SCRE-06, Recall # Z-0205-06
MANUFACTURER: Recalling Firm: Namsa, Northwood, OH, by telephone on or about March 18, 2005 and by letter on or about March 31, 2005. Manufacturer: Raven Biological Labs, Inc., Ralston, NB. Firm initiated recall is ongoing.
REASON: The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
CLASS III
PRODUCT: a) Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alarms. Monitor can monitor, display, trend and print a patient’s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2,Recall # Z-0176-06; b) Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature, and gases(i.e. five anesthetsia gases, O2, N2O, and CO2), Recall # Z-0177-06
MANUFACTURER: Datascope Corp, Mahwah, NJ, by letter on September 7, 2005. Firm initiated recall is ongoing.
REASON: Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 23, 2005:
CLASS II
PRODUCT: Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Recall # Z-0130-06
MANUFACTURER:Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated February 10, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing.
REASON: Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
PRODUCT: Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits). Recall # Z-0140-06
MANUFACTURER: Recalling Firm: Terumo Cardiovascular Systems Corp., Ann
Arbor, MI, by telephone on July 26, 2005 and by letter dated July 28,
2005.
Manufacturer: Terumo Cardiovascular Systems Corp., Ashland, MA. Firm
initiated recall is ongoing.
REASON: Small cracks in the blood chamber may allow air to enter the rotor of the device.
PRODUCT: a) D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage, Recall # Z-0142-06; b) D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad, Recall # Z-0143-06; c) D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages. Recall # Z-0144-06
MANUFACTURER: Vascular Solutions, Inc., Osseo, MN, by letter dated September 9, 2005 and by Sales Representative visit beginning September 19, 2005. Firm initiated recall is ongoing.
REASON: A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.
PRODUCT: a) Implantable Cardioverter Defibrillators: Photo DR, Model V-230HV, Recall # Z-0146-06; b) Photo Micro VR/DR, Models V-194, Recall # Z-0147-06;c) Photo Micro VR/DR, Models V-232, Recall # Z-0148-06; d) Atlas VR, Models V-199, Recall # Z-0149-06; e) Atlas DR, Model V-240, Recall # Z-0150-06
MANUFACTURER: St. Jude Medical, Sylmar, CA, by letter and press release on October 7, 2005. Firm initiated recall is ongoing.
REASON: Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent loss of defibrillation support.
PRODUCT: The Applied GelPort Hand Access Device, Model C8004, consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template, UPC Codes: C8004 +H699C80040K. Recall # Z-0151-06
MANUFACTURER: Applied Medical Resources Corp, Rancho Santa Margarita, CA, by letter on October 14, 2005. Firm initiated recall is ongoing.
REASON: The product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.
PRODUCT: Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system, Recall # Z-0153-06
MANUFACTURER: Recalling Firm: Baxter Healthcare, Renal Division, McGaw Park, IL, by letters dated August 29, 2005. Manufacturer: Mesys Gmbh, Hannover, Germany. Firm initiated recall is ongoing.
REASON: A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms without an obvious cause.
PRODUCT: Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX, Recall # Z-0154-06
MANUFACTURER: Medrad, Inc., Indianola, PA, by letter dated October 12, 2005. Firm initiated recall is ongoing.
REASON: The heat maintainer, an accessory, may overheat and deform the disposable syringe.
PRODUCT: a) Boehringer Suction Regulator, Model number: 3704, Recall # Z-0155-06; b) Boehringer Suction Regulator, Model number: 3704D3, Recall # Z-0156-06;c) Boehringer Suction Regulator, Model number: 3714, Recall # Z-0157-06
MANUFACTURER: Boehringer Laboratories, Inc., Norristown, PA, by telephone on July 25, 2005. Firm initiated recall is complete.
REASON: Condition exists that prevents complete shutoff of the valve.
PRODUCT: ICCG AC-Powered Adjustable Medical Bed, Model Numbers:1102550, 026757, 720-3M-80PR, IH720-3MQS, IH720-3M, 720-3M-76PR, IH720-2M, IHSC900, 026746, SC900-80P, SC90080L, SC900-76L, 720FULL, IHMC2MFP76, IHMC2MF80, IHMC2MF76, IHMC2MFP76, IHMC3MFP80, IHMC3ZP4I6, IHMC2M3ZP41, IHMC23ZP236, IHMC3SP23, 1H3MRFR76, IH3MRFR80, IH3MR2076, IH3MR2080, IH3MR8FR76, IH3MF8FRU6, IH3MR8FR80, IH3MF8FRU, Recall # Z-0158-06
MANUFACTURER: Invacare Corporation, Elyria, OH, by telephone and letter on July 23, 2004. Firm initiated recall is ongoing.
REASON: Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure.
PRODUCT: Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550, Recall # Z-0159-06
MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated May 5, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore. Firm initiated recall is ongoing.
REASON: A “Check Flange” alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
PRODUCT: Ohmeda Giraffe Spot PT Lite Phototherapy System, Recall # Z-0160-06
MANUFACTURER: Ohmeda Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by letter on August 5, 2005. Firm initiated recall is ongoing.
REASON: Phototherapy medical device may lose its position and can cause a safety hazard to the patient.
PRODUCT: a) Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack, Recall # Z-0163-06; b) Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; identified by the following catalog numbers: a) Cat. PO23AAMCC - Arthroscopy Kit b) Cat. PO23TKMCC - Total Knee Kit c) Cat. SOP11OPFGB - Ortho Pack d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk, Recall # 0164-06
MANUFACTURER: Cardinal Health, McGaw Park, IL, by letter dated October 3,2005. Firm initiated recall is ongoing.
REASON: The procedure kits labeled as latex-free may contain a 4’ or 6’ ultra-weave premium elastic bandage containing dry, natural rubber latex.
PRODUCT: a) S2 System, Locking Screw Partially Threaded, Catalog No. 1791-5065S to 1791-5120S; Recall # Z-0166-06; b) S2 System, Locking Screw Fully Threaded, Catalog No. 1796-5065S to 1796-5120S, Recall # Z-0167-06; c) S2 System, Condyle Screw, Catalog No. 1795-5090S to 1795-5120S, Recall # Z-0168-06; d) T2 System, Condyle Screw, Catalog No. 1895-5085S to 1895-5120S, Recall # Z-0169-06;e) Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System), Catalog No 3370-5-035 to 3370-5-090, Recall # Z-0170-06
MANUFACTURER: Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letter, on October 4, 2005. Firm initiated recall is ongoing.
REASON: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
PRODUCT: In2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). For the rapid quantification of hemoglobin A1c in whole blood, Recall # Z-0171-06
MANUFACTURER: Recalling Firm: Provalis Diagnostics, Orlando, FL, by telephone and FAX or email on May 20, 2005. Manufacturer: Provalis Diagnostics Limited, Deeside, UK. Firm initiated recall is complete.
REASON: Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.
PRODUCT: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIM method, Recall # Z-0172-06
MANUFACTURER: Recalling Firm: Dade Behring, Inc., Newark, DE, by letter on July 29, 2005. Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing.
REASON: Reports of false negative results on Sysmex Coagulation System.
PRODUCT: VITROS VANC (vancoymycin) Reagent, REF #680 1709, Recall # Z-0173-06
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters and e-mail dated October 12, 2005. Firm initiated recall is ongoing.
REASON: Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
CLASS III
PRODUCT: Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Made in the U.S.A. Recall # Z-0139-06
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, by letter on September 12, 2005. Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON: The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.
PRODUCT: Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set, Recall #Z-0141-06
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by FedEx on September 13, 2005. Manufacturer: Integra Neurosciences Ltd, Andover, UK. Firm initiated recall is ongoing.
REASON: Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
PRODUCT: BD Bard-Parker Special Surgeon’s Peridontia Blade, Sterile, Single Use, Reorder # 371712, Recall # Z-0152-06
MANUFACTURER: Recalling Firm: Becton Dickinson and Company, Franklin
Lakes, NJ, by letter on June 30, 2005. Manufacturer: Becton Dickinson
Cariba, Las Piedras, PR. Firm initiated recall is complete.
REASON: Unit packages labeled with the incorrect blade edge. The
incorrectly labeled unit packages indicate a 12 (single edged blade) is
present, the actual blade present is a 12B (double edged blade).
PRODUCT: DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm, Catalog Number: 232220, Recall # Z-0161-06
MANUFACTURER: Recalling Firm: Depuy Mitek, a Johnson & Johnson Co., Raynham, MA, by letter on August 9, 2005. Manufacturer: J-PAC, LLC, Somersworth, NH. Firm initiated recall is complete.
REASON: Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer.
PRODUCT: “Fine Tuning Your Pump” booklet provided with Model MMT-515 and MMT-715 Insulin Infusion Pumps, Recall # Z-0162-06
MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letter on April 27, 2005. Firm initiated recall is ongoing.
REASON: The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
PRODUCT: Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350, Recall # Z-0165-06
MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone, letter, and sales representative visit on August 23, 2005. Manufacturer: Biocomposites, Staffordshire, England. Firm initiated recall is complete.
REASON: The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 16, 2005:
CLASS II
PRODUCT: a) Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003, Recall # Z-0098-06;b) Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001, Recall # Z-0099-06; c) Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001, Recall # Z-0100-06
RECALLING FIRM/MANUFACTURER: Roche Diagnostics Corp., Burlington, NC, by letter dated March 28, 2005. Firm initiated recall is complete.
REASON: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
PRODUCT: Lifescan OneTouch SureStep Meter Blood Glucose monitoring system, Recall # Z-0101-06
MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letter and telephone on September 9, 2005. Firm initiated recall is ongoing.
REASON: The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
PRODUCT: Sopha Medical Vision DST / DST-XL Digital variable angle Nuclear Imaging System. Cameras affected by this safety notice are labeled with the SOPHA MEDICAL logo. STATIF DST and STATIF DST-XL model 100. The label is located on the inner side of the gantry cover. All affected cameras were manufactured prior to 1997 by Sopha Medial (SMV), which was subsequently acquired by GE Healthcare in 2000. Recall # Z-0105-06
MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated July 22, 2005. Manufacturer: Sopha Medical Systems, Inc., Cedex, France. Firm initiated recall is ongoing.
REASON: Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors.
PRODUCT: a) Meridian PA Femoral Stem, Catalog No --Description -- # of
Lots: 6261-0-001, Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002,
Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003, Meridian PA Hip Stem
#1/11MM, 107 lots; 6261-0-004, Meridian PA Hip Stem #2/10MM, 16 lots;
6261-0-005, Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006, Meridian
PA Hip Stem #3/11MM 150 lots; 6261-0-007, Meridian PA Hip Stem #3/13MM,
256 lots; 6261-0-008, Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009,
Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010,Meridian PA Hip Stem
#5/13MM, 139 lots; 6261-0-011, Meridian PA Hip Stem #5/15MM, 104 lots;
6261-0-012, Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013, Meridian PA
Hip Stem, #6/16MM, 73 lots; 6261-0-014, Meridian PA Hip Stem, #7/15MM, 21
lots; 6261-0-015, Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016,
Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017, Meridian PA Hip Stem,
#8/18, 15 lots, Recall # Z-0106-06;b) Meridian ST Femoral Stem, Catalog
#---Description -- # of lots: 6265-0-005, Meridian ST Hip Stem #2/12MM, 13
lots; 6265-0-006, Meridian ST Hip Stem #3/11MM, 3 lots; 6265-0-007,
Meridian ST Hip Stem #3/13MM, 31 lots; 6265-0-009, Meridian ST Hip Stem,
#4/14MM, 4 lots; 6265-0-011, Meridian ST Hip Stem, no # 15 lots;
6265-0-013, Meridian ST Hip Stem #6/16MM, 7 lots,
Recall # Z-0107-06; c) Reliance PF Femoral Stem, Catalog
#---Description---- # of lots: 6265-2-000, Reliance PF Hip #0/10MM, 386
lots; 6265-2-001, Reliance PF Hip #1/11MM, 484 lots; 6265-2-002, Reliance
PF Hip #2/12MM, 617 lots; 6265-2-003, Reliance PF Hip #3/13MM, 692 lots;
6265-2-004, Reliance PF Hip #4/14MM, 465 lots; 6265-2-005, Reliance PF Hip
#5/15MM, 299 lots; 6265-2-006, Reliance PF Hip #6/16MM, 184 lots;
6265-2-007, Reliance PF Hip #7/17MM, 138 lots, Recall # Z-0108-06;d)
Citation AT Femoral Stem, Catalog #-- Description-- # of lots: 6265-2-102,
Citation AT Left Hip Stem #2, 11 lots; 6265-2-103, Citation AT Left Hip
Stem #3, 15 lots; 6265-2-104, Citation AT Left Hip Stem #4, 31 lots;
6265-2-105, Citation AT Left Hip Stem #5, 31 lots; 6265-2-112, Citation AT
Left Hip Stem #2, 1 lot # P4GFD; 6265-2-113, Citation AT Left Hip Stem #3,
49 lots; 6265-2-114, Citation AT Left Hip Stem #4 , 27 lots; 6265-2-115,
Citation AT Left Hip Stem #5, 23 lots,Recall # Z-0109-06
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on August 24, 2005. Manufacturer: Stryker Ireland, Ltd., Carrigtohill, Ireland. Firm initiated recall is ongoing.
REASON: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
PRODUCT: The Lysus® Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Part number: 3929-001 Catalog number: 700-10301, Recall # Z-0110-06
MANUFACTURER: Ekos Corp., Bothell, WA, by visits starting on September 21, 2004. Firm initiated recall is complete.
REASON: The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.
PRODUCT: Lysus® Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System. Catalog # & Part #: 500-52112, 3383-002; 500-52124, 3393-004; 500-52124, 3393-006; 500-52150, 3393-007, Recall # Z-0111-06
MANUFACTURER: Ekos Corp., Bothell, WA, by letters on November 22, 2004 and by visit on March 10, 2005. Firm initiated recall is complete.
REASON: During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered.
PRODUCT: a) QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series, part number: 3006570-006 and below, Recall # Z-0116-06; b) Standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. Part number: 3006228-013 and below, Recall # Z-0117-06
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA,
by letters on September 2, 2005. Firm initiated recall is ongoing.
REASON: Potential for voltage pins in connector of therapy cable to break.
PRODUCT: Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile, Recall # Z-0124-06
MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by sales personnel on August 31, 2005. Firm initiated recall is ongoing.
REASON: The vector selector has an electrical design flaw which prevents RV pacing.
PRODUCT: Bari Maxx II, KCI’s BariMaxx II bariatric bed, P/N 310611, November 2001, Product Code 80 FNL, Recall # Z-0129-06
MANUFACTURER: Kinetic Concepts, Inc, San Antonio, TX, by letter on August 16, 2005. Firm initiated recall is complete.
REASON: Design change to upgrade reliability of powered adjustable bed.
PRODUCT: Hemosense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21, Recall # Z-0132-06
MANUFACTURER: Hemosense, Inc., San Jose, CA, by letters and telephone on September 7, 2005. Firm initiated recall is ongoing.
REASON: A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. 7.5' test message under a particular use condition." name=prdReason0
PRODUCT: a) LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; List 11235-03, Recall # Z-0133-06; b) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; list 11664-03, Recall # Z-0134-06; c) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; list 12259-02, Recall # Z-0135-06
MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated September 29, 2005. Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
PRODUCT: Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512, Recall # Z-0136-06
RECALLING FIRM/MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by fax and letter on September 29, 2005. Firm initiated recall is ongoing.
REASON: Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2.
PRODUCT: Vitros ECi Immunodiagnostic System, sold as Catalog #863 3893; Catalog #192 2814 (Vitros ECiQ), and Catalog #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units, Recall # Z-0137-06
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 29, 2005. Firm initiated recall is ongoing.
REASON: When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negatively biased.
PRODUCT: Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735, Recall # Z-0138-06
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 3, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON: If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.
PRODUCT: Optimus 30, Recall # Z-1084-06
MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by visit on/about February 24, 2004. Firm initiated recall is ongoing.
REASON: Systems do not comply with the labeling performance standards.
CLASS III
PRODUCT: Tru-Link DIN unshielded ECG cable, 5-lead, Part number: 012-0123-01, Recall # Z-0063-06
MANUFACTURER: Spacelabs Medical Inc, Issaquah, WA, by letter on September 16, 2005. Firm initiated recall is ongoing.
REASON: ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
PRODUCT: Accumetrics VerifyNow Instrument, printe power supply, Part number: 29001, Recall # Z-0102-06
MANUFACTURER: Accumetrics Inc., San Diego, CA, by letters on September 13, 2005. Firm initiated recall is ongoing.
REASON: In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.
PRODUCT: a) Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T, Recall # Z-0103-06; b) Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4, Recall # Z-0104-06
MANUFACTURER: Medical Components, Inc., dba MedComp, Harleysville, PA, by telephone on September 15, 2005. Firm initiated recall is ongoing.
REASON: The product is labeled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray.
PRODUCT: a) Arcadis Varic Mobile X-Ray System. Model number 8080017, Recall # 0118-06; b) Arcadi Orbic Mobile X-Ray System. Model number 8081080, Recall # Z-0119-06; c) Siremobil Compact Mobile X-Ray System. Model number 3776494, Recall # 0120-06; d) Siremobil Compact L Mobile X-Ray System. Model number 3780629, Recall # 0121-06; e) Siremobil Iso-C Mobile X-Ray System. Model number 2829450, Recall # 0122-06; f) Powermobil Mobile X-Ray System, Model number 2830011, Recall # Z-0123-06
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on August 11, 2005. Firm initiated recall is ongoing.
REASON: Screws may become loose and fall into the OR field during surgery.
PRODUCT: Tosoh brand Glycohemoglobin Alc Controls I & II, Catalog Number: 992133, Recall # Z-0131-06
MANUFACTURER: Recalling Firm: Tosoh Bioscience, Inc., South, San
Francisco, CA, by letter on August 18, 2005. Manufacturer: Aalto
Scientific, Ltd., Carlsbad, CA. Firm initiated recall is ongoing.
REASON: The firm has received reports that vials of the Level II were
exhibiting poor and inconsistent chromatogram quality thus affecting
control results.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 9, 2005:
CLASS II
PRODUCT: Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300, Recall # Z-0112-06
MANUFACTURER: Recalling Firm: Boston Scientific, San Jose, CA, by letters on April 1, 2005. Manufacturer: Boston Scientific, Cedex, France. Firm initiated recall is ongoing.
REASON: The device has the potential for overheating its transformer and has the potential for fire hazard.
PRODUCT: a) K 520411-2, Hercep Test, 35 Test, HER2, Protein, Recall # Z-0113-06; b) K 520711-2, Hercep Test, 35 Test, HER2, Protein, Recall # Z-0114-06
MANUFACTURER: Recalling Firm: Dakocytomation California, Inc., Carpinteria, CA, by letter dated September 29, 2005. Manufacturer: Dakocytomation, Denmark. Firm initiated recall is ongoing.
REASON: Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test Kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.
PRODUCT: Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color. All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient’s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such. Recall # Z-0128-06
MANUFACTURER: Rite-Dent Manufacturing Corp., Hialeah, FL, by letters during the week September 26, 2005. Firm initiated recall is ongoing.
REASON: At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.
CLASS III
PRODUCT: BirthNet OB Data Management System 91861, Recall # Z-0115-06
MANUFACTURER: Spacelabs Medical Incorporated, Issaquah, WA, by letters on October 13, 2004. Firm initiated recall is ongoing.
REASON: Potential for incorrect weight to be displayed.
PRODUCT: Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 individually packaged Obturators. Sterile EO. Single use, Recall # Z-0125-06
MANUFACTURER: St. Jude medical, DAIG Division, Inc., Minnetonka, MN, by letter dated September 20, 2005. Firm initiated recall is ongoing.
REASON: A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
PRODUCT: TC-Plus Solution Femoral Component, model 21028, Femoral component, right, size 8, Recall # Z-0126-06
MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA. by letter on July 23, 2005. Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
REASON: Labeling discrepancy.
PRODUCT: AMPLATZER Vascular Plug, Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments, Recall # Z-0127-06
MANUFACTURER: AGA Medical Corporation, Golden Valley, MN, by letters dated September 1, 2005. Firm initiated recall is ongoing.
REASON: Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 2, 2005:
CLASS I
PRODUCT: a) Enteryx Procedure Kit, Order No: M00572600 --US and M00572500 --OUS, Recall # Z-0040-06; b) Enteryx Injector Single Pack Order Number: M00572650 -US and M00572630 -OUS, Recall # Z-0041-06
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on September 23, 2005. Manufacturer: Life Science Outsourcing, Inc., Brea, CA. Firm initiated recall is ongoing.
REASON: Incorrect implantation may cause serious health complications. A transmural injection can result in an injection directly into a vital organ including the aorta and serious patient injury and death could occur.
CLASS II
PRODUCT: Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553, Recall # Z-0089-06
MANUFACTURER: Medrad, Inc., Indianola, PA, by an Urgent Medical Device Field Correction notice dated October 7, 2005 and October 13, 2005. Firm initiated recall is ongoing.
REASON: Overhead system can fall due to the failure of a retaining ring.
PRODUCT: Premicath 28G PICC Catheter, Recall # Z-0090-06
MANUFACTURER: Recalling Firm: Vygon Corporation, Norristown, PA, by letter on June 27, 2005. Manufacturer: Vygon GmbH & Co., Aachen, Germany. Firm initiated recall is complete.
REASON: Guidewire protruding from tip of the catheter.
PRODUCT: Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039, Recall # Z-0091-06
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated September 30, 2005. Firm initiated recall is ongoing.
REASON: The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
PRODUCT: Sienet Cosmos. Radiological Image Processing. Model number 10018971, Recall # Z-0092-06
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory dated September 22, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Reference lines appear above actual position.
PRODUCT: a) Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001), Recall # Z-0093-06; b) Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900), Recall # Z-0094-06; c) CeeOn EDGE Silicone Posterior Chamber IOLs (Models 911A and 913A), Recall # Z-0095-06; d) CeeOn Heparin Surface Modified (HSM) PMMA One-Piece Posterior Chamber- IOLs (Models:722C, 722Y, 811C, 812C and 812CU), Recall # Z-0096-06; e) CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65),Recall Z-0097-06
MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter beginning on October 5, 2005. Manufacturer: Amo Groningen, Groningen, CA. Firm initiated recall is ongoing.
REASON: A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 26, 2005
CLASS I PRODUCT: VeriCal Calibrator Set, Recall # Z-0032-06
MANUFACTURER: Biomerieux, Inc., Durham, NC, by letter, on/about August 31, 2005. Firm initiated recall is ongoing.
REASON: The product is being recalled due to mis-assignment of ISI values associated with VeriCal use. This could lead to inaccurate patient INR results.
PRODUCT: a) FreeStyle FLASH Blood Glucose Monitoring System, Recall # Z-0042-06; b) Tracker Blood Glucose Monitoring System, Recall # Z-0043-06; c) Xceed Blood Glucose Monitoring System, Recall # Z-0044-06; d) ReliOn Ultima Glucose Monitoring System, Recall # Z-0045-06; e) Kroger Glucose Monitoring System, Recall # Z-0046-06; f) RiteAid Glucose Monitoring System, Recall # Z-0047-06; g) Liberty Glucose Monitoring System, Recall # Z-0048-06; h) Boots Glucose Monitoring System, Recall # Z-0049-06; i) Optium Glucose Monitoring System, Recall # Z-0050-06; j) Xtra Classic Glucose Monitoring System, Recall # Z-0051-06; k) Easy Glucose Monitoring System, Recall # Z-0052-06; l) SofTrac Glucose Monitoring System, Recall # Z-0053-06; m) FreeStyle Glucose Monitoring System, Recall # Z-0054-06
MANUFACTURER: Abbott Diabetes Care, Inc., Alameda, CA, by letter, on June 7, 2005, and by a flyer in Precision Xtra and FreeStyle meter kits. Firm initiated recall is ongoing.
REASON: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Class II PRODUCT Nichols Advantage QuiCk-Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045, Recall # Z-0056-06
MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letter on April 14, 2005. Firm initiated recall is ongoing.
REASON: Controls were out of specification range.
PRODUCT: Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L 1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE, Recall # Z-0057-06
MANUFACTURER: Biosense Webster, Inc., Irwindale, CA, by letters dated August 8, 2005. Firm initiated recall is ongoing.
REASON: Increased complaints regarding catheters with leaks and flow obstruction.
PRODUCT: a) Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. 1 each to a package, Recall # Z-0058-06; b) Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. 1 each to a package, Recall # Z-0059-06
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 11, 2005. Firm initiated recall is ongoing.
REASON: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
PRODUCT: T2 Recon Nail System, Recall @ Z-0060-06
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 12, 2005. Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is ongoing.
REASON: The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
PRODUCT: Baxter's Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; made in Canada, Recall # Z-0061-06
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 29, 2005. Manufacturer: Baxter Healthcare Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing.
REASON: If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.
PRODUCT: Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0, Recall # Z-0064-06
MANUFACTURER: Boston Scientific, San Jose, CA, by letters on February 18, 2005 and May 18, 2005. Firm initiated recall is ongoing.
REASON: The device has the potential for overheating its transformer and has the potential for fire hazard.
PRODUCT: a) Remington Medical Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized, Recall # Z-0065-06; b) Remington Medical, Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized, Recall # Z-0066-06; c) Remington Medical, 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized; Recall # Z-0067-06
MANUFACTURER: Recalling Firm: Remington Medical Inc., Alpharetta, GA, by letter starting July 6th through July 11, 2005. Manufacturer: B. Braum Medical, Inc., Allentown, PA. Firm initiated recall is ongoing.
REASON: The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and or improper peeling of the sheath during use.
PRODUCT: Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.), Recall # Z-0068-06
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter, dated August 18, 2005. Firm initiated recall is ongoing.
REASON: The image balance center point correction algorithm used in CT image reconstruction may cause a disappearance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.
PRODUCT: a) DTX(tm) Plus DT-DL60 Continuous flush catheter, Part Number 682028, Recall # Z-0069-06; b) CRITIFLOW(tm) TA4004 continuous flush catheter, Part Number 682060, Recall # Z-0070-06; c) TAKHPQ60R continuous flow catheter, Part Number 682117. Recall # Z-0071-06; d) CRITIFLO(tm) TAK0460 continuous flow catheter, Part number 682118. Recall # Z-0072-06; e) DT-DL60-1 W/Bifurcated, Part Number 682147, Recall # Z-0073-06; f) CRITIFLO(tm) flush kit. Part Number 687198, Recall # Z-0074-06; g) CRITIFLO(tm) Flush Kit. Part Number 687566, Recall # Z-0075-06
MANUFACTURER: Recalling Firm: Becton Dickinson Medical Systems, Sandy, UT, by letter on August 22, 2005. Manufacturer: Bd Critical Care Systems P. L., Singapore. Firm initiated recall is ongoing.
REASON: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
PRODUCT: J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains, Recall # Z-0076-06
MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, by telephone and e-mail on September 2, 2005. Manufacturer: Avil Medical Products, Inc., San Diego, CA. Firm initiated recall is ongoing.
REASON: Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.
PRODUCT: a) Merit Custom Procedure Kit, Part number: K08-01894, Recall # Z0077-06; b) Merit Custom Procedure Kit, Part number: K09-08347, Recall # Z0078-06; c) Merit Custom Procedure Kit, Part number: K09-05248P, Recall # Z0079-06; d) Merit Custom Procedure Kit, Part number: K09-05248AP, Recall # Z0080-06; e) Merit Custom Procedure Kit, Part number: K09-06702, Recall # Z0081-06
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter on September 2, 2005. Firm initiated recall is complete.
REASON: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
PRODUCT: a) Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT, Recall # Z-0082-06; b) Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT, Recall # Z-0083-06
MANUFACTURER: Medrad, Inc., Indianola, PA, by letters dated September 20, 2005. Firm initiated recall is ongoing.
REASON: Stress crack on the stopcock.
PRODUCT: Serum Blood Collection Tubes, Recall # Z-0086-06
MANUFACTURER: Greiner VACUETTE North America, Monroe, NC, by letter on July 28, 2005. Firm initiated recall is ongoing.
REASON: Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
PRODUCT: Y-valve, catalog number 7427-01 and T-valve, catalog number 7990-01, PSD/4 with Valve and Syringe Drive Module parts, catalog number 51863-01-IL, Recall # Z-0087-06
MANUFACTURER: Hamilton, CO. Reno, NV, by letter and e-mail on August 24, 2005. Firm initiated recall is ongoing.
REASON: The product valve has a high probability of deforming and may result in leakage during use.
PRODUCT: Misys Laboratory version 6.1 - Microbiology Module, Recall # Z-0088-06
MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by telephone, e-mails and Product Safety Notice dated September 29, 2005. Firm initiated recall is ongoing.
REASON: Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000.
CLASS III PRODUCT: Dual Lumen Cannula, 12Fr., sterile, disposable, Model V V 12F, Recall # Z-0055-06
MANUFACTURER: Origen Biomedical, Inc., Austin, TX, by letter on December 16, 2002. Firm initiated recall is complete. REASON: Leak between two lumens causes reduced performance.
PRODUCT: HoverMatt Patient Transfer Solution/Air Transfer Mattress, Model numbers: HM28DC, HM34HS, HM34DC, HM39HS, HM39DC, Recall # z-0084-06
MANUFACTURER: D. T. Davis Enterprises, Ltd., Bethlehem, PA, by letters dated October 5, 2005. Firm initiated recall is ongoing. REASON: Instructions for use are not adhering to the product.
PRODUCT: Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30”. Model number 933B. The product is shipped in boxes containing 12 units. Recall # Z-0085-06
MANUFACTURER: Surgical Specialties Corp, Reading, PA, by fax on September 24, 2005. Firm initiated recall is ongoing.
REASON: Mislabeled as double armed straight needle.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 19, 2005
CLASS II MANUFACTURER: Recalling Firm: VIASYS Med Systems, Wheeling, IL, by telephone and fax on September 13, 2005. Manufacturer: Servicios De Ensamble Internationales S.A. de C.V., Juarez, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case. Part #10450, Catalog # SA-500/US, Recall # Z-0001-06; b) Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Steakhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case. Part #10567, Catalog # SA-300/US, Recall # Z-0002-06
REASON: The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc, Allentown, PA, by letter dated September 15, 2005. Manufacturer: Vascular Solutions, Minneapolis, MN. Firm initiated recall is ongoing.
PRODUCT: D-Start Dry Hemostatic Bandage. The product is an adhesive bandage. Recall # Z-0003-06
REASON: Package sealing defect -- product may not be sterile.
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on July 12, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Hard shell carry case for the Lifepak 500 AED. Catalog number 3005384-000 through 002, Recall # Z-0004-06; b) Hard shell carry case for the Lifepak CR Plus. Catalog number 3201582-000 through --002, Recall # Z-0005-06
REASON: Some hard shell carry case for Lifepak 500 and Lifepak CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent).
MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letter on August 30, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Nichols Advantage Invasive Trophoblast Antigen (ITA) Assay Cartridges. Catalog #62-7052, Recall # Z-0006-06; b) Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges. Catalog # 62-7039, Recall # Z-0007-06
REASON: Cartridge does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
MANUFACTURER: Abbott laboratories, Inc., Irving, TX, by letters on February 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Architect c800 for Conventional Units and SI Units, Version 5.00, Recall # Z-0008-06
REASON: Device has incorrect notation associated with therapeutic drug monitoring assays. These assays have an "IUO" notation after the results on the printed reports indicating that the results are for "Investigational Use Only". For both Conventional Units and SI Units, the ARCHITECT c8000 Assay Disk, Version 5.00 has the reagent name for Phenobarbital identified incorrectly as PHEN0 with a zero (()) instead of with the letter "O". This causes an error code to be generated during installation.
MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter dated September 6, 2005. Firm initiated recall is ongoing.
PRODUCT: Synchron LX Systems Version 4.5 Operating Software, Recall # Z-0009-06
REASON: Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on September 13, 2005. Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.
PRODUCT: Architect c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations. List number 1G06-01, Recall # Z-0010-06
REASON: Software deficiency causing potential shift in absorbance readings for test results.
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by telephone and letters on April 4, 2005. Manufacturer: Stryke, Cestas, France. Firm initiated recall is ongoing.
PRODUCT: Allocraft TLIF Bone Inserter. Catalog No. 483600100, Recall # Z-0011-06
REASON: The short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
MANUFACTURER: EBI, L.P., Parsippany, NJ, by e-mail on June 27, 205 and by letter on July 7, 2005. Firm initiated recall is ongoing.
PRODUCT: EBI Trochanteric 11mm Long Nail, Recall # Z-0012-06
REASON: Upon evaluation, the firm found that the fatigue strength of the nails was below the required value as specified in the design specification.
MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on August 3, 2005. Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) TC-PLUS Tibial Insert Ultra-Congruent Size 10; 9 mm, Model 25456, Recall # Z-0013-06; b) TC-PLUS Tibial Insert 2; 15 mm, Model 25309, Recall # Z-0014-06; c) TC-PLUS Tibial Insert UC 4; 11 mm, Model 25427, Recall # Z-0015-06; d) TC-PLUS Tibial Insert UC 4; 13 mm, Model 25428, Recall # Z-0016-06; e) TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436, Recall # Z-0017-06; f) TC-PLUS Tibial Insert UC 6; 13 mm, Model 25438, Recall # Z-0018-06; g) TC-PLUS Tibial Insert UC 10; 11 mm, Model 25457, Recall # Z-0019-06
REASON: Products did not meet specifications. The insert was produced with a smaller length dimension, resulting in micromotion experienced in preoperative assembly of a tibial insert and tibial baseplate.
MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated July 29, 2005. Firm initiated recall is complete.
PRODUCT: a) Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45. Recall # Z-0020-06; b) Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40, Recall # Z-0021-06
REASON: Screw may be incorrectly etched as to length. Screw that is etched "45mm" may be 40mm rather than 45mm. Manufacturer is recalling both lots because of a "potential of lot contamination".
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on July 25, 2005. Manufacturer: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing.
PRODUCT: Interis Allura BiPlane X-Ray System, Recall # Z-0022-06
REASON: 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter or e-mail dated August 23, 2005. Manufacturer: Zimmer Trabecular, Allendale, NJ. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. Recall # Z-0023-06; b) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046, Recall # Z-0024-06; c) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640, Recall # Z-0025-06; d) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600, Recall # Z-0026-06; e) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652, Recall # Z-0027-06; f) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246, Recall # Z-0028-06; g) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605200, Recall # Z-0029-06; h) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256, Recall # Z-0030-06
REASON: The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
MANUFACTURER: Recalling Firm: Rita Medical Systems, Fremont, CA, by letters on September 21, 2005. Manufacturer: Rita Medical Systems, Manchester, GA. Firm initiated recall is ongoing.
PRODUCT: Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401 US, Recall # Z-0031-06
REASON: Devices' sterility may be compromised as evidenced by a loss of package integrity.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated June 16, 2005. Manufacturer: Baxter Healthcare Corp./Patient Care System, Toronto, Canada.
PRODUCT: Baxter's Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015, Recall # Z-0033-06
REASON: If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.
MANUFACTURER: Stryker Instruments, Division of Stryker Corporation, Kalamazoo, MI, by letter dated August 5, 2005. Firm initiated recall is ongoing.
PRODUCT: Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000, Recall # Z-0034-06
REASON: The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
MANUFACTURER: Analogic Corporation, Peabody, MA, by letter dated September 13, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Fetalgard Lite Fetal Monitors, Model APIS (Single Fetus Monitoring), Recall # Z-0035-06; b) Fetalgard Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring), Recall # Z-0036-06
REASON: Unit may not power up due to faulty circuit board.
MANUFACTURER: Datex-Ohmeda, Inc., Madison, WI, by letter dated September 23, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Datex-Ohmeda S/5 Aespire Anesthesia System 7100, Recall # Z-0037-06; b) Datex-Ohmeda S/5 Aespire Anesthesia System 7900, Recall # Z-0038-06; c) Datex-Ohmeda Aespire Carestation. This device is not marketed in the US, Recall # Z-0039-06
REASON: Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 12, 2005:
CLASS I
MANUFACTURER: Recalling Firm: Gambro Renal Products, Lakewood, CO, by press release and letter on August 16, 2005. Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy. Firm initiated recall is ongoing.
PRODUCT: Prisma continuous renal replacement system. Model/Catalog Numbers: 018080100, 018080101, 018080001D, Recall # Z-1545-05
REASON: Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss. Failure of the operator to adequately address the cause for an ‘Incorrect Weight Change Detected” alarm and choose to continue the procedure could resulting excessive ultrafiltration.
CLASS II
MANUFACTURER: Abbott Laboratories Medisense Products, Alameda, CA, by web postings and telephone on August 30, 2005. Firm initiated recall is ongoing.
PRODUCT: FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System, Versions 1 and 2. Web Based Data Management System, no packaging. Recall #-Z-1594-05
REASON: Downloadable software obtained from the firm’s website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
MANUFACTURER: Oasis Medical, Inc., Glendora, CA, by fax and letter on August 24, 2005. Firm initiated recall is ongoing.
PRODUCT: OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2" stainless steel cannula with two 25g x 9/16" tip extensions. There are eight .25mm ports (four per tip). Recall # Z-1595-05
REASON: Foreign deposit present on the surface of the Vidaurri Lasik Flap Irrigators.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 5, 2005
CLASS I MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick MA, by letters on June 27, 2005.
Manufacturer: Boston Scientific Corporation, Wayne, NJ. Firm initiated recall is ongoing.
PRODUCT: Hemashield Vantage Vascular Graft. Vascular graft prosthesis. Recall # Z-1459-05
REASON: During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
MANUFACTURER: Lifescan Inc., Milpitas, CA, by letters on November 21, 2003, February 4, 2004, February 17, 2004 and February 9-10, 2004. Firm initiated recall is complete.
PRODUCT: LifeScan brand OneTouch Ultra Meter – Owner's Booklet, Recall # Z-1596-05. This is an extension of Z-0821-05
REASON: LifeScan brand One Touch Ultra Meter – Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)—mg/dL versus mmol/L. This error has the postential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
CLASS II MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 1, 2004. Manufacturer: Baxter Healthcare Corp., Andover, MA. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Recall # Z-1569-05; b) Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code 2L9363 and previously marketed by Sabratek under product code 606160; Product code 2L9363 is sold separately and as a component of the 6060 Pain kit, product code 2M9832P, Recall # Z-1570-05
REASON: The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm “Door Open", but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
MANUFACTURER: Angiomed Gmbh, Karlsruhe, Germany, Federal Republic of, by telephone and letter on July 26, 2005 and by letters dated July 28, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 60 mm Catalog Number: LXB08060, Recall # Z-1577-05; b) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 80 mm Catalog Number: LXB08080, Recall # Z-1578-05; c) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 100 mm Catalog Number: LXB080100, Recall # Z-1579-05; d) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 40 mm Catalog Number: LXB10040, Recall # Z-1580-05; e) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 60 mm Catalog Number: LXB10060, Recall # Z-1581-05; f) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 80 mm Catalog Number: LXB10080, Recall # Z-1582-05; g) Bard® Luminexx® Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 100 mm Catalog Number: LXB10100, Recall # Z-1583-05
REASON: Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
MANUFACTURER: Cook Urological, Inc., Spencer, IN, by telephone on July 6, 1935. Firm initiated recall is complete.
PRODUCT: Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx only, Ref G14191; Catalog No. 0073710, Recall # Z-1584-05
REASON: Mislabeled as to size.
MANUFACTURER: Recalling Firm: Brad Peripheral Vascular Inc., Tempe, AZ, by letter dated July 21, 2005. Manufacturer: Angiomed Gmbh, Karlsruhe, Germany, Federal Republic. Firm initiated recall is ongoing.
PRODUCT: Bard Luminexx 3 Biliary Stent and Delivery System, Recall # Z-1585-05
REASON: Broken stent struts of nitinol stents were noted in manufacturing.
MANUFACTURER: Guidant Endovascular Solutions, Inc., Temecula, CA, by letter on September 22, 2005. Firm initiated recall is ongoing.
PRODUCT: Guidant OTW OMNILINK.018 & .035 Biliary Stent Systems, Recall # Z-1586-05
REASON: Stents may become loose or dislodged from the delivery catheter.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone and letter on April 19, 2004. Firm initiated recall is ongoing.
PRODUCT: a) CryoValve, Pulmonary Valve & Conduit, Model # PV00, Recall # Z-1589-05; b) CryoValve, Aortic Valve & Conduit SG, Model # SGAV00, Recall # Z-1590-05; c) CryoValve, Pulmonary Valve & Conduit SG, Model # SGPPV00, Recall # Z-1591-05
REASON: Tissues associated with complaints of alleged recipient infection.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on January 26, 2004. Firm initiated recall is complete.
PRODUCT: CryoValve, Pulmonary Valve & Conduit, Donor #68538, Model # PV00, Recall # Z-1593-05
REASON: Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
CLASS III MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letters dated March 8, 2004. Manufacturer: Ortho Clinical Diagnostics, Inc., Raritan, NJ. Firm initiated recall is ongoing.
PRODUCT: Elx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall # Z-1576-05
REASON: An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek Elx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 28, 2005:
CLASS I
MANUFACTURER: Baxter Healthcare Corporation, Round Lake, IL, by letters dated February 25, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Colleague Single Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1543-05;
b) Baxter Colleague Triple Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1544-05
REASON: Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after the Battery Depleted alarm occurs.
CLASS II
*****CORRECTION*****
In the August 17, 2005, 05-33 Enforcement Report, Recall # Z-1062-05 B. Braun Tearaway Sheath should not include the following: Catalog number 612122, Lot number 0060752209, and Catalog number 612124 lot numbers 0060755565 and 0060759158.
MANUFACTURER: Linvatec Corp, Largo, FL, by letter on February 23, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Product is an Orthopedic device contained in a
Peel Foil Pouch. Product is labeled in part:
"REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable
Driver, STERILE", Recall # Z-1547-05;
b) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: "REF C6121H
QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver,
Preloaded with One #2 Herculine Suture, STERILE",
Recall # Z-1548-05;
c) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF C6120A
QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm,
Sterile, Recall # Z-1549-05;
d) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF, QTY 1,
Hornet Disposable Inserter, BioStinger Implant,
STERILE, Recall # Z-1550-05;
e) Product is an Orthopedic device contained in a Peel
Foil Pouch. Product is labeled in part: REF, QTY 1
BioScrew XtraLok, STERILE, Recall # Z-1551-05
REASON: There is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed, prior to sterilization. Therefore there is a potential for compromised sterility of the devices.
MANUFACTURER: Recalling firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated May 3, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Flo-Gard 6201 Volumetric Infusion Pump,
catalog #2M8063, 2M8063R (refurbished), 2M8063G
(global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B,
Recall # Z-1552-05;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric
Infusion Pump, catalog #2M8064, 2M8064R (refurbished),
2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D &
2M8064B, Recall # Z-1553-05
REASON: The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letters on May 16, 2005. Manufacturer: Stryker Spine, Cestas, France. Firm initiated recall is ongoing.
PRODUCT: The TRIO Spondylolisthesis Reduction Instrument is a Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis. Catalog No: 48905110, Recall # Z-1554-05
REASON: The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
MANUFACTURER: Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on May 20, 2005. Firm initiated recall is complete.
PRODUCT: Clinitron At Home Air Fluidized Therapy Bed, Recall # Z-1555-05
REASON: Sudden unexpected lowering of the head of the bed may occur due to failure of the head of the bed actuator.
MANUFACTURER: Recalling Firm: Cordis Corporation, Miami Lakes, FL, by letter on May 11, 2005. Manufacturer: Cordis Europa N.V., Roden, Netherlands. Firm initiated recall is ongoing.
PRODUCT: Product is a Powerflex P3 Dilation Catheter, Recall # Z-1556-05
REASON: During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.
MANUFACTURER: Recalling Firm: BD Medical Systems, Sandy, UT, by telephone and fax on July 1, 2005. Manufacturer: BD Critical Care Systems, Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: a) BD DTX Plus, 60" complete single-line pressure
monitoring kit, Part Number 682000, Recall # Z-1557-05;
b) BD DTX Plus, 60" complete dual-line pressure
monitoring kit, Part Number 682007, Recall # Z-1558-05;
c) BD DTX Plus, 72" complete single-line pressure
monitoring kit, Part number 682014, Recall # Z-1559-05;
d) BD DTX Plus, Stand-alone pressure transducer
with 3cc/hr flush device, Part number 682018,
Recall # Z-1560-05;
e) BD DTX Plus, 12" single-line neonatal pressure
monitoring kit. Part number 682040, Recall # Z-1561-05;
f) BD DTX Plus, Custom single-line neonatal pressure
monitoring kit, Part number 687104, Recall # Z-1562-05;
g) BD DTX Plus, Custom single-line pressure monitoting kit.
Part number 687196, Recall 3 Z-1563-05;
h) BD DTX Plus, Custom triple-line pressure monitoring kit.
Part number 687206, Recall # Z-1564-05;
i) BD DTX Plus, Custom dual-line pressure monitoring kit.
Part number 687341, Recall # Z-1565-05
REASON: Actuating tab may detach from the stopcock body, allowing fluid leak.
MANUFACTURER: Encore Medical Lp, Austin, TX, by letter on July 28, 205. Firm initiated recall is ongoing.
PRODUCT: Encore Reverse Shoulder Prosthesis (RSP), Recall # Z-1566-05
REASON: Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
MANUFACTURER: Datascope Corp, Mahwah, NJ, by letter on August 19, 2005. Firm initiated recall is ongoing.
PRODUCT: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20, Recall # Z-1567-05
REASON: The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
MANUFACTURER: North Coast Medi-Tek Inc., Mentor, OH, by telephone on June 7, 2005. Firm initiated recall is ongoing.
PRODUCT: Ultrasound probe cover, sterile. Catalog No. 910811, Recall # Z-1571-05
REASON: Unsealed packages.
MANUFACTURER: Enpath Medical, Inc., Plymouth, MN, by letter dated September 2, 2005. Firm initiated recall is ongoing.
PRODUCT: Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. The Enpath Deflectable Catheter is a flexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage. Recall # Z-1573-05
REASON: Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.
MANUFACTURER: Power Surgical Solutions, Fort Worth, TX, by letter on September 1, 2005. Firm initiated recall is ongoing.
PRODUCT: Medtronic Midas Rex Classic, GS and Legend dissecting tools, Rx only, Single Use Only, Recall # Z-1574-05
REASON: Potential compromise of sterile packaging for disposable dissecting tools.
MANUFACTURER: Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by letter on September 2, 2005. Manufacturer: Alcon Laboratories, Inc., Houston, TX. Firm initiated recall is ongoing.
PRODUCT: Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm's Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.), Recall # Z-1575-05
REASON: Unknown residue noted on surface of flap irrigators incorporated into custom paks.
CLASS III
MANUFACTURER: Recalling Firm: C.R. Bard Inc., Urological Division, Covington, GA, by letter on/about August 17, 2005. Manufacturer: Bard Sdn Bhd, Nogales Sonora, Mexico. Firm initiated recall is ongoing.
PRODUCT: Bard Davol Reliavac® 400 Closed Wound Suction Kit, Sterile/EO * Single use * Medium-Large 3/16" (15 Fr., 4.7mm) O.D. PVC Drain * 12.5" (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components are provided together in a kit but not pre-assembled. Catalog Number: 0034630, Recall # Z-1568-05
REASON: An incorrect Y-connector was placed in the kit.
MANUFACTURER: North Coast Medi-Tek, Inc., Mentor, OH, by telephone on January 18, 2005. Firm initiated recall is ongoing.
PRODUCT: SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case. Recall # Z-1572-05
REASON: Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 21, 2005:
CLASS II
****CORRECTIONS****
In the August 24, 2005 Enforcement Report: Recall # Z-1112-05, PASV Central Venous Catheter was listed as a Class II Recall, it has been determined to be Class III.
MANUFACTURER: Avid Medical, Inc., Toano, VA, by letter on September 7, 2005. Firm initiated recall is ongoing.
PRODUCT: Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company***Sterile~Disposable~Single Use Only***, and further identified by the following catalog numbers: BOOZ001-01 CATARACT PACK*** VMLR0009-05 FEM POP*** AZSS001-01 SINGLE SHOT EPIDURAL TRAY*** META026-01 SHOULDER*** MPOC002-02 ARTHROSCOPY PACK*** MMMC002 UNIVERSAL ARTHROSCOPY PACK*** ORHS023-03 OBSTETRICAL PACK W/POUCH*** MSCB002-02 BASIC PACK*** ADVH002-08 OPEN HEART KLICH PACK*** ADVM005-02 PACEMAKER-IL MASONIC*** CILS004-03 EXTREMITY PACK*** NOIN004 ARTHROGRAM PACK*** RMRI036-11 TOTAL JOINT PACK*** NRSC0003-06 ARTHROSCOPY PACK*** AV10584-03 COMMUNITY RETINAL DETACHMENT*** STJN030-02 HEART DRAPE TRAY*** STJN045 HEART OFF PUMP*** PHLS008-04 SPECIAL PROCEDURES PACK*** UHSN035-02 TOTAL KNEE*** SLIZ004a-02 CATH TRAY*** NYOD008 Abdominal Preservation Kit*** NYOD011 PEDIATRIC ABDOMINAL*** FAMC017-05 MAJOR BASIN SET*** AGAK005-04 BASIN SET-SURGERY CENTER*** AV010773-02 C-SECTION PACK*** OSUM018-04 OPHTHALMOLOGY CUSTOM TRAY*** KENT005-01 CAROTID*** HVCCA-10 HEART PACK*** SUMM004-04 Harris Basic*** MCVA0020-07 BUNDLE, EYE*** MCVA0025-04 BUNDLE, LOWER EXTREMITY*** MCVA0033-06 PDS, MAJOR EAR*** MCVA0039-06 PDS, TOTAL KNEE*** MCVA0044-02 PACEMAKER PACK*** NAPO0014-04 LAP CHOLE CUSTOM TRAY*** NAPO0025-05 HAND & PODIATRY TRAY*** NAPO0061-02 ABDOMINOPLASTY CUSTOM TRAY*** LIFE0027-06 C.V. TRANSPORT BOX*** WIAS002-01 UNIVERSAL BLOCK TRAY*** UMCW013-07 TOTAL KNEE PDS***, Recall # Z-1398-05
REASON: Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.
MANUFACTURER: Linvatec Imaging, Santa Barbara, CA, by letter on August 3, 2005. Firm initiated recall is ongoing.
PRODUCT: Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished), Recall # Z-1531-05
REASON: Surface contamination, stress, and excessive heat around the optical taper surface may result in a low light output that can create poor illumination of the surgical site.
MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated July 29, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Boston Scientific brand LeVeen Needle Electrode,
5.0/13/15; Model number M001262160, Ref 26-216,
Recall # Z-1541-05;
b) Boston Scientific brand LeVeen Needle Electrode,
5.0/13/25; Model number M001262170,Ref 26-217,
Recall # Z-1542-05
REASON: Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
MANUFACTURER: Recalling Firm: CHdiagnostics, Plymouth, MN, by e-mail, Sales Representatives visit, and letters on March 14, 2005. Manufacturer: Cambridge Sensors Limited, Huntingdon, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening, Recall # Z-1546-05
REASON: A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
CLASS III
MANUFACTURER: Scanlan International, Inc., Saint Paul, MN, by letters on July 27, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Scanlan Premier Jacobson Micro Scissors, spring
style, flat handle, V-neck, 125-degree angled
micro fine blades, 6-1/4", 16 cm. Catalog Number
7007-449. Recall # Z-1532-05;
b) Scanlan Premier Jacobson Micro Scissors, spring
style, flat handle, V-neck, 125-degree angled micro
fine blades, 8î, 20 cm. Catalog Number 7007-449-8,
Recall # Z-1533-05;
c) SCANLAN Premier Jacobson Micro Scissors, Spring
Style, round handle, V-neck, 125-degree angled
micro fine blades, 6-1/2", 16.5 cm. Catalog no.
7007-499, Recall # Z-1534-05;
d) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, V-neck, 125-degree angled
micro fine blades, 8", 20 cm. Catalog no. 7007-499-8,
Recall # Z-1535-05;
e) SCANLAN Premier Jacobson Micro Scissors, spring style,
flat handle, V-neck, 125-degree angled nano blades,
6-1/8", 15.5 cm. Catalog no. 7007-548,
Recall # Z-1536-05;
f) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, 90-degree angled nano blades,
6-12", 16.5 cm. Catalog no. 7007-596,
Recall # Z-1537-05;
g) SCANLAN Premier Jacobson Micro Scissors, spring
style, round handle, V-neck, 125-degree angled
nano blades, 6-1/2", 16.5 cm. Catalog no. 7007-598,
Recall # Z-1538-05
REASON: Some scissors purchased before May 1, 2005 may not perform properly. They may have a crack in the blade that could break.
MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter on June 27, 2005. Firm initiated recall is ongoing.
PRODUCT: XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12, Recall # Z-1539-05
REASON: The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.
MANUFACTURER: Trek Diagnostic Systems, Cleveland, OH, by letter dated August 8, 2005. Firm initiated recall is ongoing.
PRODUCT: VersaTREK Myco AS, Recall # Z-1540-05
REASON: Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 14, 2005:
CLASS II
MANUFACTURER: Biomerieux, Inc, Durham, NC, by letter on May 27, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Bac T/ALERT’ 3D Control Module, Recall # Z-0612-05;
b) Bac T/ALERT’ 3D Combination Module, Recall # Z-0613-05; c) Bac T/ALERT’
3D 60, Recall # Z-0614-05;
REASON
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric
Bac T/ALERT PF bottle.
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated May 16, 2005. Firm initiated recall is complete.
PRODUCT: a) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 57.5 mm, stainless steel;
Ref. 32-485101, Recall # Z-1445-05;
b) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 60 mm, stainless steel;
Ref. 32-485102, Recall # Z-1446-05;
c) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 62.5 mm, stainless steel;
Ref. 32-485103, Recall # Z-1447-05;
d) Biomet Vanguard microplasty slidex femoral
4-in-1 block, 80 mm, stainless steel;
Ref. 32-485108, Recall # Z-1448-05;
e) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, x-small, stainless steel;
Ref. RD140629, Recall # Z-1449-05;
f) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, small, stainless steel;
Ref. RD140630, Recall # Z-1450-05;
g) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, medium, stainless steel;
Ref. RD140631, Recall # Z-1451-05;
h) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, large, stainless steel; Ref. RD140632,
Recall # Z-1452-05;
i) Biomet Ascent SI knee instruments sliding femoral
4-in-1 block, x-large, stainless steel;
Ref. RD140633, Recall # Z- 1453-05;
j) Biomet Maxim SI knee instruments sliding femoral
4-in-1 block 55 mm, stainless steel; Ref. RD140529,
Recall # Z-1454-05;
k) Biomet Maxim SI knee instruments sliding femoral
4-in-1 block, 60 mm, stainless steel;
Ref. RD140530, Recall # Z-1455-05
REASON: The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated July 25, 2005. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240, Recall # Z-1456-05
REASON: The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated July 29, 2005. Firm initiated recall is ongoing.
PRODUCT: Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP, Recall # Z-1457-05
REASON: The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break intraoperatively.
MANUFACTURER: Recalling Firm: Becton-Dickinson & Co., Sparks, MD, by fax, e-mail, and letters on July 28, 2005. Manufacturer: Becton-Dickinson Diagnostics, Madison, WI. Firm initiated recall is ongoing.
PRODUCT: Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box, Recall # Z-1458-05
REASON: Microbiological media for antibiotic susceptibility testing gives false test results.
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated July 19, 2005. Firm initiated recall is ongoing.
PRODUCT: VITROS Chemistry GENT Reagent REF 680 1711, *** Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Recall # Z-1460-05
REASON: Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on August 12, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. : Firm initiated recall is ongoing.
PRODUCT: a) Magnetom Avanto. Magnetic Resonance Imaging
System. Model number 7391167, Recall # 1528-05;
b) Magnetom Espree. Magnetic Resonance Imaging System.
Model number 10018165, Recall # Z-1529-05
REASON: There is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore. As a result, there may be gaps between the patient table and the magnet cover. If this occurs, there is an increased risk that fingers or other body parts may become caught in the gap when moving the patient table.
MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letters on March 16, 2005. Firm initiated recall is complete.
PRODUCT: Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac), Recall # Z-1530-05
REASON: Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
CLASS III
MANUFACTURER: Recalling Firm: Sammons Preston Rolyan, Bolingbrook, IL, by letters dated July 13, 2005. Manufacturer: ITO Co., Ltd, Inashiki-gun, Japan. Firm initiated recall is ongoing.
PRODUCT: TM-300 Traction System; an Rx software driven device used for patient traction, Product No. A501-009, Recall # Z-1444-05
REASON: The traction device may malfunction, producing oscillation and a jerking motion.
MANUFACTURER: North Coast Medi-Tek, Inc., Mentor, OH, by telephone on June 23, 2004. Firm initiated recall is ongoing.
PRODUCT: E-Z-EM brand, Basic biopsy tray, catalog no. 4125. Recall # Z-1523-05
REASON: Product contains the incorrect lot number.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 7, 2005:
CLASS II
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Deerfield, IL, by letters dated June 14, 2005. Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
PRODUCT: a) Baxter System 1000 Single Patient Hemodialysis
Systems, product codes SYS1000L3, SYS1000L3P,
SYS1000L3T, SYS1000L3TD, SYS1000L2C2;
Recall # Z-1394-05;b) Baxter Arena Hemodialysis Systems, product codes
ARENADPX, ARENASP, ARENADPP, ARENASPX;
Recall # Z-1395-05
REASON: Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.
MANUFACTURER: Guidant Cardiac Surgery, Santa Clara, CA, by letter on July 5, 2005. Firm initiated recall is ongoing.
PRODUCT: Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button, Recall # Z-1396-05
REASON: Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device.
MANUFACTURER: Recalling Firm: Biosound Esaote, Inc., Indianapolis, IN, by letters dated May 2, 2005, May 6, May 9 and May 13, 2005. Manufacturer: Esaote Biomedica S.P.A., Firenze, Italy. Firm initiated recall is ongoing.
PRODUCT: a) MyLab30CV Ultrasound Imaging System; model 9807300000,
Recall # Z-1401-05;b) MyLab30CV Ultrasound Imaging System; model
9807300001,
Recall # Z-1402-05;
c) MyLab25 Ultrasound Imaging System; model 9807300002,
Recall # Z-1403-05
REASON: Data maybe corrupted upon re-opening archived files.
MANUFACTURER: Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about July 29, 2005 Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is ongoing.
PRODUCT: Radiomat Lightweight Cassettes, Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes, Recall # Z-1404-05
REASON: Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
MANUFACTURER: ITW Dymon, Olathe, KS, by telephone on February 15, 2005 and by letters on February 21, 2005 and April 29, 2005. Firm initiated recall is ongoing.
PRODUCT: a) ITW Dymon Medaphene Plus Disinfectant
Spray, Pseudomonacidal, Virucidal, Mildewcidal,
Fungicidal, Staphylocidal, Tuberculocidal,
packaged in 20-oz. steel aerosol cans, net wt
16-oz. (1-lb.), 12 cans/case, containing 0.19% o-
phenylphenol and 68.00% ethyl alcohol, Product
34720. The firm name on the label is ITW Dymon.
The product is also sold under the following
private labels: (1) Renown Disinfectant Deodorant
II, Product REN05013, Distributed by AmSan, LLC;
(2) Decon Aerosol Disinfectant, Catalog #8617;
(3) New Jax Medaphene Plus Disinfectant Spray;
(4) San-O-Phene Plus Disinfectant Spray,
Sold By San Joaquin Supply Co.;
(5) Sterling Quality Hospital Use Micro II
Disinfectant Spray, Distributed By Sterling
Sanitary Supply Corporation; (6) Ball-Phene
Spray Disinfectant, Reorder #3U037;
(7) Area Two-In-One Disinfectant Spray Original,
Sold By Area Distributors, Inc.;
(8) Benefax Disinfectant Spray, Exclusively S
Sold By Biotek Corporation; (9) Pheno-Cen Spray
Disinfectant/Deodorant, Sold By Central
Solutions, Inc.; (10) Clark Bio-Phene Plus
Disinfectant/Spray, Sold By Clark Paper Plus
Inc.; (11) LOGIChem Hosp-I-Septic Disinfectant
Spray, Distributed Exclusively For Edmar;
(12) Morcept Hospital Disinfectant, Sold By Moore
Research, Inc.; (13) Pro Chem Deocept Purity
Hospital Disinfectant, Sold By Pro-Chem, Inc.,
(14) Select Specialty Products Spectrum II
Hospital Type Disinfectant, Sold By Select
Specialty Products, Recall # Z-1405-05;
b) ITW Dymon Medaphene Plus Orange Disinfectant Spray,
Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz.
steel aerosol cans, net wt 16-oz. (1-lb.), 12
cans/case, containing 0.19% o-phenylphenol and
68.00% ethyl alcohol, Product 52920. The firm
name on the label is ITW Dymon. The product is also
distributed under the following private labels:
O.D.S. Orange Disinfectant Spray, Continental
Research Corporation; (2) Drummond American Bristol Orange Disinfectant
Spray, Product DR8561, Sold by Drummond American Corporation; (3) Romaine
Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For
Romaine Companies; (4) State Discover Aerosol Disinfectant Citrus, Stock
#109566 and #109567, Sold By State Industrial Products; (5) Medisan
Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply; (6)
DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold
by DETCO Industries; (7) Orange Disinfectant Spray, Manufactured for
MASSCO, Inc.; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc.; (9)
Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of
DM Resources, Inc.; (10) Citrus-Cidal Disinfectant Spray, Orange
Fragrance, Sold By navy brand Manufacturing Company; (11) Pro Chem Deocept
Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc.; (12)
Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold
Exclusively By Ricmar Industries, Inc.; (13) Neutron NI-712 Disinfectant
Spray, Stock #104787, A product of Neutron Industries, Recall # Z-1406-05;
c) ITW Dymon Medaphene Plus Lemon Disinfectant Spray,
Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz.
steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/
case, containing 0.19% o-phenylphenol and 68.00%
ethyl alcohol, Product #52820. The firm name on the
label is ITW Dymon. The product is also distributed
under the following private labels: (1) Renown Lemon
Disinfectant Deodorant, Distributed by AmSan, LLC;
Concept Lemon Scented Disinfectant Deodorant,
Product 5282057750, Sold By Manny's Sanitary Supplies, Inc., Recall #
Z-1407-05;
d) ITW Dymon Medaphene Plus Country Garden Disinfectant
Spray, Pseudomonacidal, Virucidal, Mildewcidal,
Fungicidal, Staphylocidal, Tuberculocidal, packaged
in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.),
12 cans/case, containing 0.19% o-phenylphenol and
68.00% ethyl alcohol, Product #42620. The firm name
on the label is ITW Dymon. The product is also
distributed under the following private labels:
Area Two-In-One Disinfectant Spray Country,
Reorder #ADI-531, Sold By Area Distributors, Inc.;
(2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for
Lawson Products, Inc.; (3) Major Envirocide Country Fresh Disinfectant
Spray, Sold By Major Chemical Company; (4) Concept Potpourri Disinfectant
Deodorant, Sold By Manny's Sanitary Supplies, Inc.; (5) Meyer Century Zip
Hospital Disinfectant, A Product of Meyer Laboratory, Inc; (6) Pro Chem
Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc.; (7) State
Discover Aerosol Disinfectant Country Garden, Stock #109568 and and
#109569, Sold By State Industrial Products; (8) Sterling Quality Nature's
Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply
Corporation; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By
Superior Chemical Corp.; (10) Renown Potpourri Disinfectant Deodorant,
Product REN05056, Distributed by: AmSan, LLC; (11) Asepsis Asepticide
Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By
Asepsis International, Inc.; (12) Dazzle "D" Disinfectant Spray Country
Garden, Sold By Henry Kraft Inc.; (13) TB-Cide Country Garden Hospital
Disinfectant, Sold By Industrial Distributors, Inc.; (14) G-Sep Aromatic
Disinfectant Spray, Sold By Moore Research, Inc; (15) Mt. Hood Chemical
Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt.
Hood Chemical Corp.; (16) IDS Medi-Spray Country Garden Disinfectant
Deodorant, Manufactured For Sold By International Distribution System,
Inc.; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A
product of Nuetron Industries; (18) Sunrise Environmental Scientific
Disinfectant Spray Country Garden, Sold By Sunrise Environmental
Scientific; (19) United Laboratories Flower Power Disinfectant Spray,
United 135, Sold By United Laboratories, Inc. One private label is
packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant
Spray, Product 42616, Manufactured for Watkins Incorporated; Recall #
Z-1408-05
REASON: Failed EPA required efficacy testing; may not perform as intended.
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters dated March 11, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Brilliance CT System, 40 channel configuration
using version 1.2 software, Recall # Z-1409-05;
b) Brilliance CT System, 16 Power configuration
using version 1.2 or 1.2.1 software,
Recall # Z-1410-05;
c) Brilliance 16, 10, and 6 configuration
(water cooled version) using 1.0. 1.1, 1.2,
1.2.2, or 1.2.4 software, Recall # Z-1411-05;
d) Brilliance CT system, 16, 10, and 6 configuration
(air cooled version) using version 1.2 or
1.2.1 software, Recall # Z-1412-05;
e) MX8000IDT CT Scanner using version 2.5.5,
3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software,
Recall # Z-1413-05;
f) MX8000 Dual v.EXP CT Scanner using version 2.5.
software, Recall # Z-1414-05;
g) Extended Brilliance Workspace using 1.x or 2.x
software, Recall # Z-1415-05;
h) MxView using version 5.0, 5.0.1, or 4.1
software, Recall # Z-1416-05;
i) Gemini PET/CT system, Dual Configuration,
Recall # Z-1417-05;
j) Gemini 16 PET/CT system, Slice Configuration,
Recall # Z-1418-05
REASON: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on April 13, 2005. Manufacturer: Diagnostica Stago, Franconville , France. Firm initiated recall is complete.
PRODUCT: PTT-LA Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL, Cat. No. 00599, Recall # Z-1419-05
REASON: Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
MANUFACTURER: Recalling Firm: Shimadzu Medical Systems, Torrance, CA, by letter in April 2002. Manufacturer: Shimadzu Corporation, Kyoto, Japan. Firm initiated recall is complete.
PRODUCT: C-Vision Angiographic X-Ray System, Model IVS-100, Recall # Z-1420-05
REASON: Fluro exposure stuck open, will not terminate.
MANUFACTURER: Recalling Firm: GE Medical Systems Information
Technologies, Mount Prospect, IL, by letter, dated July 18, 2005.
Manufacturer: Camtronics Medical Systems, Ltd, Hartland, WI. Firm
initiated recall is ongoing.
PRODUCT: GE Healthcare Centricity Cardiology A11000 Workstation Recall # Z-1421-05
REASON: The potential exists for the A11000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.
MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NY, by letter on June 20, 2005. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
PRODUCT: STA-R blood coagulation analyzer. Catalog Number 57160, Recall # Z-1422-05
REASON: Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, on letter on July 26, 2005. Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR. Firm initiated recall is ongoing.
PRODUCT: BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve, Catalog #364880, Recall # Z-1423-05
REASON: Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated August 3, 2005. Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibon:ito, PR. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Interlink System Non-DEHP Y-Type Catheter
Extension Set, product code 2N3371; An Rx sterile,
nonpyrogenic fluid pathway, 5.7", 0.8 mL Vol.,
with 2 injection sites and a male Luer Lock adapter;
Recall # Z-1424-05;
b) Baxter Minivolume Extension Set, 72", product code
2C5687; An Rx sterile, nonpyrogenic fluid pathway,
72", 1.6 mL Vol., with a male Luer Lock adapter,
Recall # Z-1425-05;
c) Baxter Minivolume Extension Set, 36", product code
2C5685; An Rx sterile, nonpyrogenic fluid pathway,
36", 0.9 mL Vol., with a male Luer Lock adapter,
Recall # Z-1426-05;
d) Baxter Mini-Infuser Microbore Extension Set,
product code 2C9201; An Rx sterile, nonpyrogenic
fluid pathway, 61", 0.5 mL Vol., with Luer Lock
adapters, Recall # Z-1427-05;
e) Baxter Tamper Resistant Anti-Siphon PCA Extension Set,
60", product code 2C9205; An Rx sterile, nonpyrogenic
fluid pathway, 60", 1.2 mL Vol., with Luer Lock
adapters, Recall # Z-1428-05;
f) Baxter Tamper Resistant Anti-Siphon PCA Extension Set,
96", product code 2C9206; An Rx sterile, nonpyrogenic
fluid pathway, 96", 1.6 mL Vol., with Luer Lock
adapters, Recall # Z-1429-05;
g) Baxter Tamper Resistant Anti-Siphon Combination Set,
101", product code 2L3507; An Rx sterile, nonpyrogenic
fluid pathway, 101", 2.5 mL Vol., with male Luer Lock
adapter, Recall # Z-1430-05;
h) Baxter Extension Set, product code 2C9219; An Rx
sterile, nonpyrogenic fluid pathway, 61", 1.4 mL Vol.,
with Luer Lock adapters, Recall # Z-1431-05;
i) Baxter Interlink System Huber Needle Extension Set,
product code 2N3703; An Rx sterile, nonpyrogenic
fluid pathway with Needle Gauge 22, Needle Length 3/4",
Total Volume 0.40 mL, Total Length 9",
Recall # Z-1432-05;
j) Baxter Interlink System Huber Needle Extension Set,
product code 2N3706; An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection Site, Needle Gauge
19, Needle Length ¾", Total Volume 0.75 mL, Total
Length 10", Recall # Z-1433-05;
k) Baxter Interlink System Huber Needle Extension Set,
product code 2N3707; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 20, Needle Length 3/4", Total Volume
0.75 mL, Total Length 10", Recall # Z-1434-05;
l) Baxter Interlink System Huber Needle Extension Set,
product code 2N3709; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 22, Needle Length 3/4", Total Volume
0.75 mL, Total Length 10", Recall # Z-1435-05;
m) Baxter Interlink System Huber Needle Extension Set,
product code 2N3710; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 19, Needle Length 1", Total Volume
0.75 mL, Total Length 10", Recall # Z-1436-05;
n) Baxter Interlink System Huber Needle Extension Set,
product code 2N3712; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 20, Needle Length 1", Total Volume
0.75 mL, Total Length 10", Recall # Z-1437-05;
o) Baxter Interlink System Huber Needle Extension Set,
product code 2N3714; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 22, Needle Length 1", Total Volume
0.70 mL, Total Length 10", Recall # Z-1438-05;
p) Baxter Interlink System Huber Needle Extension Set,
product code 2N3716; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 19, Needle Length 1-1/2", Total
Volume 0.75 mL, Total Length 10",
Recall # Z-1439-05
REASON: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter August 8, 2005. Manufacturer: Orchard Software Corp, Carmel, IN. Firm initiated recall is ongoing.
PRODUCT: Aqueduct Hematology Workflow Manager, software, Part Number AQDCT, Recall # Z-1440-05
REASON: Potential for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. This may cause test results to be associated with the wrong patient.
MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by telephone on June 13, 2005. Manufacturer: B. Braun Medical, Inc, Cherry Hill, NJ. Firm initiated recall is ongoing.
PRODUCT: a) Guidant ENDOTAK SQ Array models 0048, 0049, 0085.
Subcutaneous Lead Array.
Cardioversion/Defibrillation Lead.
Sterilized with gaseous ethylene oxide.
Recall # Z-1441-05;
b) Guidant Lead Tunneler Kit model 6927.
Accessory Kit for use with the Endotak SQ
Lead Array. Contains one tunneler and
four sheaths. Sterilized with gaseous
ethylene oxide, Recall # Z-1442-05;
c) Oscor Introducer Kits Model LLP series.
Luer-Lock Peel-Away Introducer Set.
Each set contains: 1 peel-away sheath
with built-in-luer-lock; 1 vessel dilator;
1-50-cm guidewire 1 18-G needle; 1 10-cc
syringe. Sterile EO. Models 6089, 6091,
6092, 6093, 6094, 6663 and 6664,
Recall # Z-1443-05
REASON: A manufacturer for Guidant Introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
CLASS III
MANUFACTURER: Alsius Corporation, Irvine, CA, by letters beginning July 25, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Alsius CoolGard 3000 Temperature Regulation System, Recall # Z-1397-05;b) Alsius CoolGard 3000 Temperature Regulation System, Recall # Z-1398-05;
REASON: Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.
MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by e-mail on August 7, 2005. Firm initiated recall is on ongoing.
PRODUCT: Abbott TestPack + Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes, Recall # Z-1399-05
REASON: False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.
MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letter dated August 5, 2005. Firm initiated recall is ongoing.
PRODUCT: Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03, Recall # Z-1400-05
REASON: The value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 31, 2005:
CLASS II MANUFACTURER: Exactech, Inc, Gainesville, FL, by letter on June 2, 2005. Firm initiated recall is complete.
PRODUCT: Optetrak Finned Tibial Tray A/P 53 mm ML 83mm***4F/5T Ti Alloy Fits only SZ. 4 Femoral Cemented, Sterile, Single Use Only. For Cemented Use Only, Recall # Z-1379-05
REASON: Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated July 13, 2005. Manufacturer: Mesys Gmbh, Hannover, Germany. Firm initiated recall is ongoing.
PRODUCT: Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international), a hemofiltration system, Recall # Z-1380-05
REASON: In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy.
MANUFACTURER: Anika Therapeutics, Inc., Woburn, MA, by telephone and letters on July 14, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile, Rx, For intraocular use. P/N490-001, Recall # Z-1383-05; b) ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL, Sterile, Rx. For intraocular use. Product Number: 1000, Recall # Z-1383-05; c) Amvisc® Sodium Hyaluronate 0.5 mL, Product Number: 59051, Recall # Z-1384-05; d) Amvisc® Sodium Hyaluronate 0.8 mL, Product Number: 59081, Recall # Z-1385-05; e) Amvisc® Plus Sodium Hyaluronate 0.5 mL, Product Number: 60051, Recall # Z-1386-05; f) Amvisc® Plus Sodium Hyaluronate 0.8 mL, Product Number: 60081, Recall # Z-1387-05
REASON: Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 18, 2005. Manufacturer: Beckman Coulter, Inc, Chaska, MN. Firm initiated recall is ongoing.
PRODUCT: Access Immunoassay Systems Assay Protocol: Dil-AFP, Recall # Z-1388-05
REASON: Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX I 725 has a potential to create splashing which may cause erroneous results.
MANUFACTURER: Stryker Instruments, Div. Of Stryker Corporation, Kalamazoo, MI, by letter dated August 5, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000, Recall # Z-1389-05; b) Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000A, Recall # Z-1390-05
REASON: Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
CLASS III MANUFACTURER: International Technidyne Corp, Edison, NJ, by letter on April 27, 2005. Firm initiated recall is ongoing.
PRODUCT: Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box, Recall # Z-1381-05
REASON: Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by e-mail on March 16, 2005. Firm initiated recall is ongoing.
PRODUCT: ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Recall # Z-1392-05
REASON: False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
MANUFACTURER: Boston Scientific Corporation, Glens Falls, NY, by letters dated May 4, 2004. Firm initiated recall is complete.
PRODUCT: NAMIC Custom Angiographic Kit: (1) Pouch Catalog # 60131481; (2) Pouch Catalog #60131603; (3) Pouch Catalog #60101041; (4) Pouch Catalog #61020031 (5) Kit #65185472 ****** Each kit is customized to the needs of the particular hospital identified on the product labeling, Recall # Z-1393-05
REASON: Molded handles used in Angiographic Manifolds may be occluded.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 24, 2005:
CLASS I MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake IL, by letter on July 20, 2005. Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R, Recall # Z-1059-05; b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R, Recall # Z-1060-05
REASON: A hardware problem can cause internal communications errors, which halt therapies, generate alarms and communication failure codes.
MANUFACTURER: Recalling Firm: Guidant Corp., Saint Paul, MN, by letter dated July 22, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland, Firm initiated recall is ongoing.
PRODUCT: a) VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Recall # Z-1107-05; b) VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Recall # Z-1108-05
REASON: Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
CLASS II MANUFACTURER: Recalling Firm: Medtronic Neurosurgery, Goleta, CA, by letters on July 5, 2005. Manufacturer: B. Braun Medical, Inc., Allentown, PA, Firm initiated recall is ongoing.
PRODUCT: a) Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F, Recall # Z-1110-05; b) Medtronic Neurosurgery C/N 3805-015 Peelaway Introducer Sheath, Disposable 15 F, Recall # Z-1111-05
REASON: Cracked hubs/handles and/or improper peeling of the sheath during use.
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letters dated May 25, 2004. Manufacturer: Boston Scientific Corp., Glens Fall, NY, Firm initiated recall is complete.
PRODUCT: PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps, Recall # Z-1112-05
REASON: Kits labeled to contain 0.028í guidewire contain 0.038í guidewire.
MANUFACTURER: Medical Device Group Inc., Poway, CA, by telephone on June 8, 2005, and by letters on June 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Tri-Plex Adapter, single unit (MD-04000) or box of 25 (MD-04001) or case of 100 (MD-04002). Adaptor that is coupled between an endotracheal tube and a ventilator. Device allows practitioner to access the airway without having to disconnect the circuit. Sterile, Single Use, Recall # Z-1371-05
REASON: Device separation presenting a choking hazard. The plunger seal separated from the plunger.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake IL, by letters dated July 6, 2005. Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R; Made in Singapore, Recall # Z-1373-05
REASON: During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.
MANUFACTURER: Newport Medical Instruments, Inc., Costa Mesa, CA, by letter dated October 29, 2004 and December 20, 2004. Firm initiated recall is ongoing.
PRODUCT: Newport HT50 All Purpose Ventilator, Recall # Z-1375-05
REASON: Lack of alarm prior to shutdown.
MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letters on April 20, 2005. Firm initiated recall is ongoing.
PRODUCT: UltraLite Vehicles powered by Rascal Motorized Vehicles, Recall # Z-1376-05
REASON: The engager set screw may become loose. This problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 13, 2005. Manufacturer: Applied Cytometry Systems, Dinnington, UK. Firm initiated recall is ongoing.
PRODUCT: Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05
REASON: Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
MANUFACTURER: Cepheid, Sunnyvale, CA, by letters on July 22, 2005. Firm initiated recall is ongoing.
PRODUCT: SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05
REASON: A problem in the software has the potential to be associated with the incorrect reporting of sample results.
CLASS III MANUFACTURER: Konica Medical Imaging, Inc, Wayne, NJ, by telephone, visit, and letter, beginning on April 7, 2005. Firm initiated recall is ongoing.
PRODUCT: Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05
REASON: One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters during the week of June 20, 2005. Manufacturer: Normand Informatique, Cedex, France. Firm initiated recall is ongoing.
PRODUCT: DL2000 Data Manager, Recall # Z-1372-05
REASON: Version v6.4.109f, any result designated as ìcalculated chemistryî at DL2000 may upload to the LIS with an incorrect or blank sample ID.
MANUFACTURER: Recalling Firm: Dade Behring, Inc., Newark DE, by letters on July 13, 2005. Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing.
PRODUCT: Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test, Recall # Z-1374-05
REASON: Sample may exhibit falsely high results.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 17, 2005:
CLASS II MANUFACTURER: Recalling Firm: Maquet Inc, Bridgewater, NJ, by letter on May 20, 2005. Manufacturer: Jostra Ag, Hirrlingen, Germany. Firm initiated recall is ongoing.
PRODUCT: Polystan Coronary Cannula Balloon Tip( Cardiopulmonary bypass vascular catheter), Recall # Z-1061-05
REASON: Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheterís FDA approval status.
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on May 27, 2005. Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
PRODUCT: Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INTRADYN TEAR-AWAY INTRODUCER 8F; INTRADYN TEAR-AWAY INTRODUCER 9F; INTRADYN TEAR-AWAY INTRODUCER 10F; INTRADYN TEAR-AWAY INTRODUCER 11F; INTRADYN TEAR-AWAY INTRODUCER 12F; INTRADYN TEAR-AWAY INTRODUCER 15F; INTRADYN TEAR-AWAY INTRODUCER 16F; 23HI120 12F X 23CM HEMO INTRO; 23HI130 13F X 23CM HEMO INTRO; 30STA8 8FR X30CM T/A INTRO -NJ*; 30STA9 9FR X 30CM SHEATH -NJ*; 30STA10 10FR X 30CM T/A INTRO -NJ*; 30STA12 12FR X 30CM T/A INTRO -NJ*; 30STA16 16FR X 30CM SHEATH; BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; 45STA9 45CM T/A INTRODUCER -NJ*; LUTHER 6F - T/A ASSM CLIP; 10HI14038 14F X 11CM HEMO W/WI; BOSTON SCI 12FX 21.35 DIL/SHEATH; 10HI12038 12F X 11CM HEMO W/WI; 10HI13038 13F X 11CM HEMO W/WI; BOSTON SCI 9F X 9.54 STEP DIL/SH; BOSTON SCI 9F X 15.44 STEP DIL/SH; BOSTON SCI 9F X 21.35 STEP DIL/SH; BOSTON SCI 11F X 9.54 STEP DIL/SH; BOSTON SCI 11F X 15.44 STEP DIL/SH; BOSTON SCI 12F X 9.54 DIL/SHEATH; BOSTON SCI 12F X 15.44 DIL/SHEATH; BOSTON SCI 14F X 9.54 DIL/SHEATH; BOSTON SCI 14F X 15.44 DIL/SHEATH; BOSTON SCI 16F X15.44 DIL/SHEATH; 30STA15 15FR LONG TA INTRODUCR; 30STA11 11FR LONG TA INTRODUCR -NJ*; CARDIAC PACEMAKER T/A SHEATH; 14FR TA DILATOR/SHEATH-BULK; 12FR INTRODUCER TEAR AWAY BNS; 12FR TA DIL/SHEATH LC; 8FR TA SHEATH; 10FR TA SHEATH; 16FR TA SHEATH; 8/10FR LOCK T/A INTRO STEPPED; 6FR T/A DILATOR/SHEATH; 6FR LOCKING T/A INTRO ASSY; 14FR X 143MM LOCKING T/A INTRODUCERS; PTFE 4.5 FR BARD ACCESS INTRODUCERS; PTFE 6.0 FR BARD ACCESS INTRODUCERS; 7F LOCKING INTRO SYSTEM; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; 9 FR (0/S) LOCKING INTRO SYSTEM; 12F LOCKING INTRO SYSTEM; 14FR LOCKING T/A INTRODUCER; 10FR X 18 CM LOCKING T/A INTRODUCER; 14FR X 12MM LOCKING T/A INTRODUCER; 10.5FR X 18CM LOCKING T/A INTRODUCER; 10FR X 23CM LOCKING T/A INTRODUCER; 10FR LOCKING TEAR-AWAY INTRODUCERS; INTRADYN TEAR-AWAY INTRODUCER 10.5F; 30STA14 14FR X 30CM T/A INTRO -NJ*; BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY; CELSA 5FR LOCKING T/A INTRODUCER; CORDIS 4" BLUNT TIP T/A SHEATH; MEDTRONIC PS MED INTRO ASM 14F -NJ*; MEDTRONIC PS MED INTRO ASM 15F. Recall # Z-1062-05
REASON: Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
MANUFACTURER: Encore Medical, Lp, Austin, TX, by e-mail on June 7, 2005. Firm initiated recall is ongoing.
PRODUCT: Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries, Recall # Z-1063-05
REASON: Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by Sales Representatives on June 16, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) PRIZM 2 DR, model 1861 Automatic Implantaable Cardioveter Defibrillator, Contents have been Sterilized with gaseous ethylene oxide, Recall # Z-1064-05; b) CONTAK Renewal 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator, Contents have been sterilized with gaseous ethylene oxide, Recall # Z-1065-05
REASON: Devices were manufactured with PEEK insulation material on the feed through wires and distributed prior to PMAS approval. MANUFACTURER: Power Surgical Solutions, Fort Wayne, TX, by letter on July 1, 2005. Firm initiated recall is ongoing. PRODUCT: Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor, Recall # Z-1067-05 REASON: Complaints of finger control component breaking off and falling into open surgical wound.
MANUFACTURER: Chad Therapeutics Inc, Chatsworth, CA, by letter on March 25, 2005. Firm initiated recall is ongoing.
PRODUCT: Sequoia Oxymatic electronic oxygen conservers, Models OM-302 and OM-311, Recall # Z-1068-05
REASON: ìShot sizeî below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
MANUFACTURER: Cobe Cardiovascular, Inc., Arvada, CO, by letter beginning June 22, 2005. Firm initiated recall is ongoing.
PRODUCT: a) ASY Brat 2 Procedure Set, for blood recovery & autotransfusion, Catalog Number 007213100, Recall # Z-1069-05; b) ASY, Brat 2 Pack Procedure Set, Catalog Number: 007213102, Recall # Z-1070-05; c) ASY Brat 2 Procedure Set, Catalog Number: 007214100, Recall # Z-1071-05; d) ASY, Brat Pack Procedure Set, Catalog Number: 007214102, Recall # Z-1072-05; e) ASY Brat 2 Procedure Set, Catalog Number: 007214900, Recall # Z-1073-05; f) ASY, Brat 2 Procedure Set, Castalog Number:007214901, Recall # Z-1074-05
REASON: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, by letters and telephone on June 27, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ì***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE *FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended*** Carton Label ì***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/ REORDER NO. 093205***This device is designed for the administration and removal of fluids*** Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***, Recall # Z-1076-05; b) Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing Set***1 Zero Port Plug, Serrated***1 Monitor Line Labels***STERILE EO***STERILIZED BY EtO***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE*** Carton Labeling: ***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***Quantity: 10 ea***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE STERILE EO***STERILIZED BY EtO***, Recall # Z-1077-05; c) Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ***Argon Medical Device***REORDER NO./REF 193205*** 10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY EtO*** Sterile Unless Opened or Damaged*** Carton Label ***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids* REF/REORDER NO. 193205***Quantity: 25 ea *STERILE***EO***STERILIZED BY EtO***DISPOSABLE ***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile Unless Opened or Damaged***, Recall # Z-1078-05; c) Labeling is as follows: Product Labeling: ***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or repacking.*** Carton Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/ REORDER NO. 094337***Quantity: 20 ea***NON- STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***, Recall # Z-1079-05; d) Labeling is as follows: Product Labeling: ***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended****** Carton Labeling: ***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administration and removal of fluids.***Quantity: 250 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***, Recall # Z-1080-05; f) Labeling is as follows: Product labeling: ***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.*** DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE*** STERILE EO***STERILIZED BY EtO*** Carton Labeling: ***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir*** This device is designed for the administration and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***STERILE EO*** STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***, Recall # Z-1081-05
REASON: The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
MANUFACTURER: Recalling Firm: Del Pharmaceuticals, Inc., Farmingdale, NY, by letters on June 9, 2005 and July 21, 2005, and by press release on June 10, 2005. Manufacturer: Yi Shing, Hong Kong, China. Firm initiated recall is ongoing.
PRODUCT: Orajel toddler Extra Gentle Yellow Manual Toothbrush, Model 7531, barcode # 3 10310 32362 2. Made in China -- The toothbrush is to be replaced every 3 months, Recall # Z-1082-05
REASON: Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated July 11, 2005. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
PRODUCT: Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box, product number RLA-142-3, Recall # Z-1083-05
REASON: There is a lack of assurance of sterility for parts of both lots of product.
MANUFACTURER: Recalling Firm: Puritan Bennett, Pleasanton, CA, by letter on April 20, 2005. Manufacturer: Puritain Bennett, Galway, Ireland. Firm initiated recall is ongoing.
PRODUCT: Puritan Bennett 840 Series Ventilator Power Supply, Model/Catalog Numbers: 4-076314-00; 4-076314-SP, Recall # Z-1085-05
REASON: Some of the screws from inside the power supply were loose or missing altogether. Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated May 4, 2005. Manufacturer: Avail Medical Products, Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Recall # Z-1086-05; b) Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Recall # Z-1087-05
REASON: The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter on June 13, 2005. Manufacturer: Baxter Healthcare, Corp., Singapore. Firm initiated recall is ongoing.
PRODUCT: a) Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L, 606000-40I; Recall # Z-1088-05; b) Baxter 6060E Epidural Infusion Pump, product code 2L9351 and 606000-40EL; Recall # Z-1089-05
REASON: There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed.
MANUFACTURER: Warsaw Orthopedic, Inc., Warsaw, IN, by letter, on May 27, 2005. Firm initiated recall is ongoing.
PRODUCT: Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 23 mm; Catalog number 8941423, Recall # Z-1090-05
REASON: The product is labeled as sterile, but this lot was not sterilized.
MANUFACTURER: Recalling Firm: United States Surgical Corp., North Haven, CT, by letter dated June 30, 2005. Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
PRODUCT: a) ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011, Recall # Z-1091-05; b) ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120021, Recall # Z-1092-05; c) ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter Catalog Number: 120025, Recall # Z-1093-05; d) ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath Catalog Number: 120039, Recall # Z-1094-05; e) ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120045, Recall # Z-1095-05; f) ChemoSite Implantable venous access sytem with printed silicone Catheter and 9 French Introducer Kit Catalog Number: 120066, Recall # 1096-05; g) ChemoSIte Cathteter Introducer Kit with 7 French Peel-Away Sheath Catalog Number: 120089, Recall # Z-1097-05; h) ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120092, Recall # Z-1098-05
REASON: The peel away introducer sheath may have cracked hubs/handles and/or improper peeling of the sheath during use.
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated July 6, 2005. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11", 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Recall # Z-1099-05; b) Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16î, 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter; Recall # Z-1100-05; c) Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18î, 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Recall # Z-1101-05; d) Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9", 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Recall # Z-1102-05; e) Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6î, 0.33 mL Vol., with male Luer Lock adapterRecall # Z-1103-05
REASON: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in under delivery of medication, blood loss, and a breach of the sterile fluid pathway.
MANUFACTURER: Datascope Corp, Mahwah, NJ, by letter on June 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Panorama Patient Monitoring Network Cardiac Arrhythmia Monitor, Recall # Z-1104-05
REASON: Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on July 15, 2005, by telephone and letters on July 18, 2005, and by press release on July 28, 2005. Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters. Recall # Z-1105-05
REASON: The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
MANUFACTURER: Recalling Firm: Staar Surgical Co. Inc., Monrovia, CA, by telephone, email and letter on July 18, 2005.
Manufacturer: Anika Therapeutics, Woburn, MA. Firm initiated recall is ongoing.
PRODUCT: Staarvisic II Sodium Hyaluronate, 0.8 mL, Recall # Z-1106-05 REASON: Sterility may be compromised.
MANUFACTURER: Inogen, Inc., Goleta, CA, by letter on August 1, 2005. Firm initiated recall is complete.
PRODUCT: Portable Oxygen Generator, Recall # Z-1368-05
REASON: Firm plans to upgrade all units to correct situations that could lead to interruption in oxygen delivery.
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letters dated June 7, 2005. Manufacturer: Sanmina SCI, County Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT: ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. Recall # Z-1370-05
REASON: The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.
CLASS III ***CORRECTION*** In the July 20, 2005 Enforcement Report, Recall # Z-0974-05, Recalling Firm and Manufacturer is Theragenics Corporation, Buford, GA.
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated April 6, 2005. Manufacturer: Zimmer Caribe, Inc., Mercedita, PR. Firm initiated recall is complete.
PRODUCT: Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32mm dia., neck length +0mm; Product 00-8018-032-02, Recall # Z-1066-05
REASON: Mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters and telephone on April 9, 2005. Manufacturer: Peg Bandages, Inc., Las Piedras, PR. Firm initiated recall is ongoing.
PRODUCT: BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ìstab incisionsî. A non sterile, disposable, stainless steel blade. Reorder Number 371631, Recall # Z-1075-05
REASON: A small percentage of scalpels exhibited a ìdouble bladeî condition.
MANUFACTURER: Recalling Firm: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 3, 2005. Manufacturer: Body Media, Inc., Pittsburgh, PA. Firm initiated recall is ongoing. PRODUCT: Roche Diagnostic Health Wear brand Professional System for weight management; Catalog # 04344456001, Recall # Z-1113-05 REASON: Lack of adequate manufacturing controls.
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letters on May 5, 2005 .Manufacturer: I D S Co., Ltd., Bolden, England. Firm initiated recall is ongoing.
PRODUCT: Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556, Recall # Z-1369-05 REASON: Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 3, 2005:
CLASS I MANUFACTURER: Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated July 18, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) DISCOVERY pacemaker (model nos. 1174, 1175, 1273, 1274 and 1275). Recall # Z-1032-05; b) MERIDIAN pacemaker (model nos. 476, 976, 1176 and 1276), Recall # Z-1033-05; c) PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker, Recall # Z-1034-05; d) PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker, Recall # Z-1035-05; e) DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker, Recall # Z-1036-05; f) VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker, Recall # Z-1037-05; g) INTELES II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker, Recall # Z-1038-05; h) CONTAK TR (model no. 1241) pacemaker, Recall # Z-1039-05
REASON: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.
CLASS II MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letters on April 22 and 29th, 2005. Firm initiated recall is ongoing.
PRODUCT: Nichols Advantage ACTH Test System, catalog number 62-7004, Recall # Z-1044-05
REASON: Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
MANUFACTURER: Ohmeda Medical, A division of Datex-Ohmeda, Inc., Laurel, MD, by letter on April 25, 2005. Firm initiated recall is ongoing.
PRODUCT: Ohmeda Medicalís Giraffe? OmniBeds and Giraffe Incubators, Recall # Z-1047-05
REASON: Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letters dated March 5, 2004. Manufacturer: Boston Scientific Corp, Glens Falls, NY. Firm initiated recall is complete
PRODUCT: a) PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK Material Number M001PIC402CK0, Recall # Z-1049-05; b) PICC Catheter - 4.5 Fr Dual Lumen Catalog #PIC402CKIR, Material Number M001PIC402CKIRO, Recall # Z-1050-05; c) PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKMSO, Recall # Z-1051-05; d) PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen, Catalog #60M120522. UPN M00160M1205220, Recall # Z-1052-05
REASON: Lumens may have incorrect lumen size marked on them. The smaller capacity proximal fitting is on the larger handling volume lumen and the larger capacity proximal fitting on the smaller handling lumen. This may result in a slower rate of infusion.
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by telephone and letter on May 25, 2005. Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.
PRODUCT: a) BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL Syringe. Recall # Z-1053-05; b) # 309603 -- Syringe 5Ml LL syringe, Recall # Z-1054-05; c) # 309604 -- Syringe 10 mL LL, Recall # Z-1055-05; d) #309661 -- Syringe only ll 20 mL, Recall # Z-1056-05; e) #309644 -- 10 ml syringe with 20 G1' Needle, Recall # Z-1057-05; f) #309604 -- 10 mL syringe, Recall # Z-1058-05
REASON: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
CLASS III MANUFACTURER: Recalling firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letters on June 10, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
PRODUCT: Mammomat Novation Digital Mammography System. Model number 646900, Recall # Z-1045-05
REASON: Potential issue (image acquisition may become interrupted) when using multiple network nodes.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter dated May 31, 2005. Manufacturer: Command Medical Products, Ormond Beach, FL. Firm initiated recall is ongoing.
PRODUCT: Baxter Interlink System Huber Needle Extension Set; a sterile 10î fluid pathway with an Interlink Y --Injection Site and ¾î x 22 gauge needle, Recall # Z-1048-05
REASON: Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 27, 2005:
CLASS I
MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL, by letter on March 15, 2005. Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: a) Baxter Colleague Single Channel Volumetric Infusion Pumps, product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05; b) Baxter Colleague triple Channel Volumetric Infusion Pumps, product codes: 2M8153, 2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05
REASON: The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
CLASS II
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on May 27, 2005. Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
PRODUCT: a) Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS, Recall # Z-0995-05; b) Right Heart Catheter Product Line: Catalog Number 601258-----WP604P Wedge Press Catheter, Recall # Z-0996-05; c) Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Catheter, Recall # Z-0997-05; d) Right Heart Catheter Product Line: Catalog Number 601272-----WP1106 Wedge Press Catheter, Recall # Z-0998-05; e) Right Heart Catheter Product Line: Catalog Number 601276-----WP1107 Wedge Press Catheter, Recall # Z-0999-05; f) Right Heart Catheter Product Line: Catalog Number 601285-----WP11055 Wedge Press Catheter, Recall # Z-1000-05; g) Right Heart Catheter Product Line: Catalog Number 601293-----WP1107S Monitory Wedge Press, Recall # Z-1001-05; h) Right Heart Catheter Product Line: Catalog Number 604000-----417D10061 Recall # Z-1002-05; i) Right Heart Catheter Product Line: Catalog Number 604025-----T046-02 0426D10091 RMM, Recall # Z-1003-05; j) Right Heart Catheter Product Line: Catalog Number 604028-----T047(90) 427D10221, Recall # Z-1004-05; k) Right Heart Catheter Product Line: Catalog Number 604037-----T047-02 0427D10061, Recall # Z-1005-05; l) Right Heart Catheter Product Line: Catalog Number 604057----T147 A427D1014KANI, Recall # Z-1006-05; m) Right Heart Catheter Product Line: Catalog Number 604100----T147-03 A427D1014KANI 25PP, Recall # Z-1007-05; n) Right Heart Catheter Product Line: Catalog Number 604103-----T047(97) 427D4036I, Recall # Z-1008-05; o) Right Heart Catheter Product Line: Catalog Number 604165-----T047-04 0427D1022I, Recall # Z-1009-05; p) Right Heart Catheter Product Line: Catalog Number 604239-----426D1009I, Recall # Z-1010-05; q) Right Heart Catheter Product Line: Catalog Number 604264-----427D1006I Round Molded Manifold, Recall # Z-1011-05; r) Right Heart Catheter Product Line: Catalog Number 604315-----406-1H-018 426D1009I18PP, Recall # Z-1012-05; s) Right Heart Catheter Product Line: Catalog Number 608054-----827D1006I 4P BBM RMM Catheter, Recall # Z-1013-05; t) Right Heart Catheter Product Line: Catalog Number 608055-----827D1006I 4P BBM RMM Catheter, Recall # Z-1014-05
REASON: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
MANUFACTURER: Recalling Firm: Diagnostic Products Corp, Los Angeles, CA, by telephone and letter on May 26, 2005. Manufacturer: EURO/DPC Limited. Firm initiated recall is ongoing.
PRODUCT: Immulite/Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1, Recall # Z-1015-05
REASON: Adverse trend in stability, controls biased or out of range.
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated May 26, 32005. Firm initiated recall is ongoing.
PRODUCT: Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Recall # Z-1016-05
REASON: Falsely elevated Carbamazepine results.
MANUFACTURER: St Jude Medical, Sylmar, CA, by letter on June 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Implantable Cardioverter Defibrillators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242),and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343), Recall # Z-1017-05
REASON: Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL, by letters on June 21, 2005 and June 22, 2005. Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
PRODUCT: a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, Recall # Z-1018-05; b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R, Recall # Z-1019-05
REASON: The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
MANUFACTURER: Recalling Firm: Boston Scientific Marlborough, Marlborough, MA, by letter dated June 28, 2005. Manufacturer: Nexcore Technology, Inc., Hackensack, NJ. Firm initiated recall is ongoing.
PRODUCT: Adapter for ACMI Hysteroscope, Catalog Number: 55035, Recall # Z-1020-05
REASON: The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.
MANUFACTURER: Recalling Firm: Depuy Orthopedics, Inc, Warsaw, IN, by letter dated June 10, 2005. Manufacturer: Depuy Ireland, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640. Recall # Z-1024-05; b) Depuy brand LCS Complete metal backed patella, porocoat, STD+; REF 1294-09-650; Recall # Z-1025-05; c) Depuy brand LCS Complete metal backed patella, porocoat, LRG; REF 1294-09-660. Recall # Z-1026-05; d) Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670, Recall # Z-1027-05; e) Depuy brand LCS Complete metal backed patella, cemented, STD; REF 1294-09-740. Recall # Z-1028-05; f) Depuy brand LCS Complete metal backed patella, cemented, STD+; REF 1294-09-750, Recall # Z-1029-05; g) Depuy brand LCS Complete metal backed patella, cemented, LRG; REF 1294-09-760, Recall # Z-1030-05; h) Depuy brand LCS Complete metal backed patella, cemented, LRG+; REF 1294-09-770, Recall # Z-1031-05
REASON: There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
MANUFACTURER: Recalling Firm: Dade Behring, Inc., Newark, DE, by letter dated June 17, 2005. Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing.
PRODUCT: Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E, Recall # Z-1040-05
REASON Positive control shows weak agglutination reaction.
MANUFACTURER: Beckman Coulter Inc, Brea, CA, by letters on or about June 20, 2005. Firm initiated recall is ongoing.
PRODUCT: Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Unit) 988610 (LH Connection Unit), Recall # Z-1041-05
REASON: Risk of injury to workers due to mechanical or electrical hazards. Corrective action will include shields, covers, software interlocks, a spill tray, and edge smoothing.
MANUFACTURER: Recalling Firm: Core Brands, Baltimore, MD, by telephone on June 17, 2005, and by letters on June 21, 2005. Manufacturer: Ningbo Powerwell Fine Chemical Industrial Co., Ltd., Ningbo, China. Firm initiated recall is ongoing.
PRODUCT: Healing Labsô Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, Made in China, UPC 087399430205. Packed 48 boxes/case. Recall # Z-1042-05
REASON: Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
MANUFACTURER: Recalling Firm: Arthocare Corp, Sunnyvale, CA, by letters on July 12, 2005.
Manufacturer: Clearform Plastics Ltd., North Shields Tyne& Wear NE298SE, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, Catalog number 22-1006, Recall # Z-1043-05
REASON: Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection.
CLASS III
MANUFACTURER: DPC Cirrus, Flanders, NJ, by letter on April 22, 2005. Firm initiated recall is ongoing.
PRODUCT: IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use, Recall # Z-0994-05
REASON: In the Tube Transport Chain Sensor, used to move a Reaction Tube within the Immulite 2000, a false trigger can occur due to particulate contamination or dust. Although extremely remote, this behavior can cause the instrument to process a test using an incorrect bead. The failure occurs when debris in the sensor triggers the signal, indicating the flag was detected before the chain reaches position. In this case, the Processor Shuttle pushes a blank space, and the instrument generates an error "473 - Reaction Cup is not in the pipetting position." The reaction cup containing the bead remains on the chain and moves to the pipette position for the launch of the next test. Meanwhile, the reaction cup intended for the current test remains in the indexer, where a second bead is dispensed. This generates an error "408 - Two beads detected rerunning test". The test is question is launched between the two errors. After these two cycles the instrument returns to normal operation.
MANUFACTURER: Boston Scientific Corporation, Glens Falls, NY, by telephone on June 24, and June 30, 2004, and by letter on October 18, 2004. Firm initiated recall is complete.
PRODUCT: EMCEE Obturator (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Recall # Z-1021-05
REASON: Product labeled to contain Emcee Obturators contained Emcee Dilators.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 20, 2005:
CLASS I
MANUFACTURER: Vail Products, Inc., Toledo, OH, by letter, dated May 6, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Vail 500 Enclosed Bed System, Recall # Z-0861-05 b) Vail 1000 Enclosed Bed System, Recall # Z-0862-05 c) Vail 2000 Enclosed Bed System, Recall # Z-0863-05
REASON: Risk of patient entrapment, may result in serious injury or death.
MANUFACTURER: Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letters, dated May 23, 2005 and June 17, 2005, and by press release on May 25, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing. PRODUCT: Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy. Recall # Z-0906-05 REASON: Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjunction with other factors, resulted in an electrical short. The short may cause diversion of shock therapy energy away from the heart and into device circuitry.
MANUFACTURER: Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by press release and letter dated June 17, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0907-05; b) CONTAK RENEWAL 2 (model H155) Heart Failure Device. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0908-05
REASON: Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
CLASS II
MANUFACTURER: Recalling Firm: Qualitest Pharmaceuticals, Inc, Huntsville, AL, by press release and letter on June 14, 2005.
Manufacturer: Shin Chang Medical Co., Ltd, Gumi-Shi, Kyungsangbuk-Do, Korea. Firm initiated recall is ongoing.
PRODUCT: AccuSure Insulin Syringe, lcc, 28 guage, ½”, packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21, Recall # Z-0942-05
REASON: Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated April 21, 2005.
Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica. Firm initiated recall is ongoing.
PRODUCT: Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids, Recall # Z-0943-05
REASON: There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
MANUFACTURER: Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated June 23, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0949-05; b) CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0950-05; . c) CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157 and M159) Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 3 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0951-05; d) CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0952-52; e) CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 4 RF devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall # Z-0953-05
REASON: Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
MANUFACTURER: Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated June 17, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) Ventak Prizm Avt model no, 1900, Atrial and Ventricular Therapies, Recall # Z-0954-05; b) Ventak Prizm Avt model A135 and model A155. Implantable, Cardioverter Defibrillator. Atrial and Ventricular Therapies, Recall # Z-0955-05; c) CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies, Recall # Z-0956-05
REASON: The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional “latching” that limits available therapy.
MANUFACTURER: Philips Medical Systems (Cleveland), Inc, Cleveland, OH, by letter, dated March 23, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Ultra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips, Recall # Z-0957-05; b) AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips, Recall # Z-0958-05
REASON: Software anomaly in the DICOM Modality Worklist. When restoring a patient’s images from the optical disk, images from the wrong patient may be displayed.
MANUFACTURER: Motion Control, Inc., Salt Lake City, UT, by telephone, on February 1, 2005. Firm initiated recall is ongoing.
PRODUCT: Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered upper limb prosthesis, Recall # Z-0959-05
REASON: Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.
MANUFACTURER: Abbott Laboratories, Columbus, OH, by letter, dated June 16, 2005. Firm initiated recall is ongoing.
PRODUCT: 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442), Recall # Z-0960-05
REASON: The kits contain a 12 Fr. Introducer Tear-Away BNS component. The tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots.
MANUFACTURER: Recalling Firm: Smiths Medical International Ltd, Hythe, UK, by letter dated June 3, 2005.
Manufacturer: Smiths Healthcare Manufacturing Sa De Cv, Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT: Portex HEPA Bacterial/Viral Filter, Non-Latex Ref: 002890, Recall # Z-0961-05
REASON: Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label.
MANUFACTURER: Boston Scientific Corp, Spencer, IN, by letter dated June 7, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 18/2.4, pull; Catalog number 6314. Z-0962-05; b) Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820. Recall # Z-0963-05; c) Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, push; catalog number 6821. Recall # Z-0964-05; d) Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824. Recall # Z-0965-05; e) Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, push; catalog number 6825. Recall # Z-0966-05; f) Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838. Recall # Z-0967-05; g) Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog number 6839. Recall # Z-0968-05; h) Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848. Recall # Z-0969-05; i) Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/2.4 pull; catalog number 6851. Recall # Z-0970-05; j) Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852. Recall # Z-0971-05; k) Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/1.7 push; catalog number 6860. Recall # Z-0972-05
REASON: Two blades may be heat staked onto the stiletto instead of the expected one blade.
MANUFACTURER: Recalling Firm: Straumann Manufacturing, Inc., Andover, MA, by letter dated June 6, 2005.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is complete.
PRODUCT: RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560, Recall # Z-0975-05
REASON: Basal screw is too short to adequately hold the dental abutment in the implant.
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 18, 2005. Manufacturer: Sanmina SCI, Fermoy, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) Accu-Chek Compact Blood Glucose Meter; catalog number 3183572, Recall # Z-0976-05; b) Accu-Chek Compact Care Kit; catalog number 3149137, Recall # Z-0977-05
REASON: The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 18, 2005.
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing. PRODUCT: a) Accu-Chek Instant Blood Glucose Meter; Catalog numbers 914 and 924, Recall # Z-0978-05; b) Accu-Chek Instant Care Kit; Catalog number 91490, Recall # Z-0979-05
REASON: The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
MANUFACTURER: LifeScan Inc, Milpitas, CA, by letters on June 9, 2005. Firm initiated recall is ongoing.
PRODUCT: LifeScan brand One Touch UltraSmart Blood Glucose Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner’s Booklet AW 060-788-01A are affected by this Field Correction. Recall # Z-0980-05
REASON: Meter labeling (Owner’s Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message “Do you need a snack” for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, “Do you need a snack?” for glucose values from 20 through 59 mg/d. MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL, by letters dated March 10, 2005.
Manufacturer: Baxter Healthcare, Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing.
PRODUCT: Clinician Workstation Software, product code 2M5042, Recall # Z-0981-05
REASON: The medication administration results displayed in the “View Results” link may be inaccurate.
MANUFACTURER: Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter on May 23, 2005. Manufacturer: Toshiba, Japan. Firm initiated recall is ongoing.
PRODUCT: Aplio Diagnostic Ultrasound System (SSA-770A), Recall # Z-0982-05
REASON: If the measurement mode is started from the Doppler mode and then sweep speed setting is changed by the assigned user function, the measurement of the time direction results don’t correspond to the actual values.
MANUFACTURER: Roche Molecular Systems, Inc., Somerville, NJ, by letter on February 14, 2005. Firm initiated recall is complete.
PRODUCT: TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS), Recall # Z-0983-05
REASON: Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on June 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Lifepak 20 defbrillator/monitor, Part numbers: 3202487-xxxd and 3202488-xxx, Recall # Z-0984-05
REASON: The device defibrillator may not operate if the device is turned on during an AC Loss Alert.
MANUFACTURER: Natus Medical, Inc, San Carlos, CA, by letter, on June 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.) Recall # Z-0985-05
REASON: Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
MANUFACTURER: Recalling Firm: Toshiba American Med Systems, Inc, Tustin, CA, by letter on May 25, 2005. Technicians will correct the software by visit beginning on May 25, 2005. Manufacturer: Matsushita Communication Industrial Co., Ltd, Hanishina-Gun, Japan. Firm initiated recall is ongoing.
PRODUCT: Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05
REASON: Patient information A is displayed with images of patient B.
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on June 10, 2005. Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.
PRODUCT: a) Axiom Aristos TX. Model number 58 94 873 Radiology system, Recall # Z-0988-05; b) Axiom Aristos MX/VX. Model number 58 95 003, Recall # Z-0989-05; c) Axiom Aristos FX. Model number 74 14 803, Recall # Z-0990-05
REASON: Potential issue (system may lock up) when repeating patient registrations.
MANUFACTURER: Warsaw Orthopedic, Inc., Warsaw, IN, by letter dated June 20, 205. Firm initiated recall is ongoing.
PRODUCT: a) Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016, Recall # Z-0991-05; b) Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018, Recall # Z-0992-05; c) Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. Recall # Z-0993-05
REASON: The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
CLASS III MANUFACTURER: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, by letter dated April 6, 2005. Firm initiated recall is ongoing.
PRODUCT: Smith & Nephew Grasper, Cupped 3.4mm REF: 011014, Recall # Z-0973-05
REASON: Cupped Grasper Handle marked incorrectly as Duckbill Upbiter.
MANUFACTURER: Recalling Firm: Theragenics Corporation, Buford, GA, by telephone and email on May 16, 2005. Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.
PRODUCT: PG910 Spacers, Part number SP101, loaded into Bard® Express Seeding Cartridges containing TheraSeed® Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch. Recall # Z-0974-05
REASON: The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.
MANUFACTURER: Recalling Firm: Allergan Medical Optics, Inc., Santa Ana, CA, by letter on June 13, 2005. Manufacturer: Advanced Medical Optics Manufacturing Spain, Alcobendas (Madrid), Spain. Firm initiated recall is ongoing.
PRODUCT: Claris Cleaning and Soaking Solution, 4 fl. oz., Recall # Z-0987-05
REASON: Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 13, 2005:
CLASS II
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on June 8, 2005.
Manufacturer: Boston Scientific Corporation, Glens Falls, NY. Firm initiated recall is ongoing.
PRODUCT: a) Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M001453330. Recall # Z-0944-05; b) Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Recall # Z-0945-05; c) Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Recall # Z-0946-05
REASON: Potential for port housing separation after implantation.
MANUFACTURER: Hill-Rom, Inc., Batesville, IN by letter dated May 20, 2005. Firm initiated recall is ongoing.
PRODUCT: Hill-Rom Century+ Bed, Model P1400. Recall # Z-0948-05
REASON: Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side.
CLASS III
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL, no official recall notification was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is complete
PRODUCT: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R, Recall # Z-0947-05
REASON: The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 6, 2005:
CLASS II
MANUFACTURER: FHC, Inc, Bowdoinham, ME, by letter dated March 14, 2005 and March 25, 2005. Firm initiated recall is ongoing.
PRODUCT: FHC 66-ZD-MD micro Targeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN), Recall # Z-0895-05
REASON: Potential for non-sterile pin to contaminate sterile field.
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 29, 2005.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT: View Forum 2003 software, SW 3.4L1, Recall # Z-0896-05
REASON: Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
MANUFACTURER: Aspen Surgical Products, Inc, Byron Center, MI, by telephone on May 15, 2005. Firm initiated recall is complete.
PRODUCT: Dr. Fog Endoscopic fog prevention kit, Recall # Z-0897-05
REASON: An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
MANUFACTURER: HK Surgical Inc, San Juan Capistrano, CA, by letters on December 3, 2004, April 11-14, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23; HK12C15; HK12C23; HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6, Recall # Z-0898-05 b) Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8, Recall # Z-0899-05 c) Gold Hub Monty Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15, Recall # Z-0900-05
REASON: Risk of hubs becoming disconnected from the cannula.
MANUFACTURER: Invacare Corporation, Elyria, OH, by telephone between May 9 and May 25, 2005, and by letter dated April 2005. Firm initiated recall is ongoing.
PRODUCT: a) Pronto Series Power Wheelchair, model M50, Recall # Z-0901-05 b) Pronto Series Power Wheelchair, model M51, Recall # Z-0902-05 c) Pronto Series Power Wheelchair, model M61, Recall # Z-0903-05
REASON: If the arm of the wheelchair is overloaded, the joystick mounting bracket and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
MANUFACTURER: Efoora, Inc. dba Virotek, L.L.C., Buffalo Grove, IL, by fax and DHL delivery on May 5, 2005 through May 27, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton, Recall # Z-0904-05 b) Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box and stock code 5000115, packaged in single unit blue cap packaging, 200 per box, Recall # Z-0905-05
REASON: The sterility of the lancets may be compromised due to inadequate packaging seals.
MANUFACTURER: Harmony Brands Llc, Oak Park, MI, by press release on March 25, 2005 and by letter beginning on March 28, 2005. Firm initiated recall is ongoing.
PRODUCT: a) B-Sure brand one step home pregnancy test, Items 28030 (case of 48 kits) and 28031 (case of 144 kits), Recall # Z-0909-05 b) Lover brand lubricated latex condoms in various presentations, item numbers 29042, 29044, 29045, 29047, 29095, 29095D, 29096, 29097, 29111, 29112, 29145, 29146, 29147 and 29148, Recall # Z-0910-05 c) Lover brand lubricated latex condoms spermicidal, item number 29043, Recall # Z-0911-05
REASON: Lack of assurance of safety and efficacy; products are from unknown sources.
MANUFACTURER: Abbott Laboratories, East Windsor, NJ, by letter on March 16, 2005. Firm initiated recall is ongoing.
PRODUCT: i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world). Recall # Z-0912-05
REASON: Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
MANUFACTURER: Esa Biosciences, Inc, Chelmsford, MA, by letter and telephone beginning May 19, 2005. Firm initiated recall is ongoing.
PRODUCT: LeadCare Blood Lead Testing System Kits, Catalog number: 70-2233, Recall # Z-0914-05
REASON: Lead test results may be reported lower than the actual value
MANUFACTURER: Instrumentation Laboratory Co, Lexington, MA, by an Urgent Product Notification on May 19, 2005. Firm initiated recall is ongoing.
PRODUCT: ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent, Models: 290001 999001, Recall # Z-0915-05
REASON: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy.
MANUFACTURER: Carroll Healthcare Inc, London, Ontario, Canada, by fax on May 17, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE. Recall # Z-0919-05 b) Carroll Healthcare brand Spirit bed; models BBH2180- 111AE, BBH2180-111PE and BBH2180-111FE. Recall # Z-0920-05
REASON: The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
MANUFACTURER: Recalling Firm: Varian Medical Systems, Charlottesville, VA, by Customer Technical Bulletin on April 14, 2005. Manufacturer: Willy Rusch AG GmbH, Kernen-Rommelshausen, Germany. Firm initiated recall is ongoing
PRODUCT: Flexible Implant tube, blind end, 350 mm, part #GM11003730, Available as single unit or contained in the Flexible Interstital Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device. Recall # Z-0921-05
REASON: A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by letter on May 13, 2005. Firm initiated recall is ongoing.
PRODUCT Envisor, M2540 Diagnostic Ultrasound System, Part numbers: 453561193003, SW C.O.O. Recall # Z-0923-05.
REASON: A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone beginning June 2, 2005. Manufacturer: Intraplant AG, Cham, Switzerland. Firm initiated recall is complete.
PRODUCT: Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807, Recall # Z-0924-05
REASON: Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long. RECALLING FIRM/MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on March 16, 2005.
Manufacturer: Becton-Dickinson P R, Inc, Juncos, PR. Firm initiated recall is ongoing.
PRODUCT: BD 25G Spinal Needles. (Spinal Anesthesia Needle), Recall # Z-0928-05
REASON: A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the presence of a slight sink in the taper surface.
MANUFACTURER: Animas Corporation, West Chester, PA, by letter on April 11, 2005, telephone on April 12, and April 25, 2005. Firm initiated recall is ongoing.
PRODUCT Animas Model IR 1250 Insulin Pump, Recall # Z-0929-05
REASON Pump failed to respond to keypad button presses after using the food database feature.
MANUFACTURER: Smiths Medical ASD, Inc, Gary, IN, by letter dated April 26, 2005. Firm initiated recall is ongoing. PRODUCT: Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5 mm obturator; product code 67P035, Recall # Z-0930-05 REASON: The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
MANUFACTURER: Recalling Firm: Boston Scientific Scimed, Maple Grove, MN, by letters on April 19, 2005.
Manufacturer: Boston Scientific Corp, Wayne, NJ. Firm initiated recall is ongoing.
PRODUCT: PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. Recall # Z-0931-05
REASON: Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
MANUFACTURER: Recalling Firm: Kendall Healthcare Products Co, Mansfield, MA, by visits on April 27 and 28, 2005. Manufacturer: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY. Firm initiated recall is complete.
PRODUCT: Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Recall # Z-0932-5
REASON: Holes in thermoformed tray compromising the sterility of the product.
MANUFACTURER: Masimo Corporation, Irvine, CA, by letter on June 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Radical Handheld Pulse Oximeter, Recall # Z-0933-05
REASON: Speaker component failure resulting in cessation of an audible alarm even though the condition continues that caused the alarm.
MANUFACTURER: Ev3, Plymouth, MN, by visit on June 10, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Ev3 Protégé GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65- 09-60-120. Sterile EO, Single Use, Recall # Z0934-05 b) Ev3 Protégé GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65- 08-20-120. Sterile EO, Single Use, Recall # Z0935-05 c) Ev3 Protégé GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65- 10-30-120. Sterile EO, Single Use, Recall # Z0936-05
REASON: 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length).
MANUFACTURER: Beckman Coulter, Inc, Brea, CA, by letters on May 20, 2005. Firm initiated recall is ongoing.
PRODUCT: Potassium Electrode Tip; Part No.s: 668281 Tip Assembly - Synchron Family 669117 Packaged - Synchron Family 441104 Electrode Assembly-EL-ISE 445604 Electrode Packaged- EL-ISE, Recall # Z-0937-05
REASON: Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on May 13, 2005. Firm initiated recall is ongoing.
PRODUCT: Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall # Z-0938-05
REASON: Software anomaly may rarely allow modification of previously reported specimen results.
MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by Product Safety Notice on May 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Mysis Laboratory version 6.1, Recall # Z-0939-05
REASON: When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more susceptibilities on the culture will be deleted.
MANUFACTURER: Wilson-Cook Medical Inc, Winston Salem, NC, by email/fax on June 17, 2005. Firm initiated recall is ongoing.
PRODUCT: a) CLBS-7-12* Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035"/480 CM. *Pushing Catheter: 7 FR. Disposable - Single Use Only - Rx Only, Recall # Z-0940-05 b) Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable - Single Use Only, Recall # Z-0941-05
REASON: The reorder number listed on the product label is inaccurate.
CLASS III MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter on March 24, 2005. Firm initiated recall is ongoing.
PRODUCT: AxSYM total B-hCG Ragent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. Recall # Z-0893-05
REASON: Abbott Diagnostics is investigating a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter on March 24, 2005. Firm initiated recall is ongoing.
PRODUCT: IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent, Recall # Z-0894-05
REASON: Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated March 15, 2005.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: VITROS Immunodiagnostic Products TOTAL T4 Reagent Pack, Ref #874 4468, 100 coated wells. Recall # Z-0913-05
REASON: Potential for positively biased results in QC and patient samples.
MANUFACTURER: EBI, L.P., Parisippany, NJ, by letter on March 16, 2005. Firm initiated recall is ongoing.
PRODUCT: a) EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055. Recall # Z-0916-05 b) EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060. Recall # Z-0917-05 c) Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640. Recall # Z-0918-05
REASON: The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
MANUFACTURER: Manan Medical Products, Inc., Wheeling, IL, by letters on May 3, 2005. Firm initiated recall is complete.
PRODUCT: Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - Recall # Z-0922-05
REASON: The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures
MANUFACTURER: BioHorizons Implant Systems, Inc., Birmingham, AL, by telephone and email on June 3, 2005. Firm initiated recall is ongoing.
PRODUCT: a) The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm, Recall # Z-0925-05 b) The Maestro System 225-312, Profile Abutment for Cement, 5mm, Recall # Z-092605
REASON: The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
MANUFACTURER: Recalling Firm: Stillwater, MN, by letter on November 1, 2004. Manufacturer: Euro Diagnostica AB, Malmo, Sweden. Firm initiated recall is ongoing.
PRODUCT: DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Made in the United Kingdon. Recall # Z-0927-05
REASON: DiaSorin Anti-Cardiolipin IgA Kit, positive control was on the low limit of the acceptable range (1-35 U/mL).
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 22, 2005:
CLASS I ****CORRECTION**** The Enforcement Report 05-20 dated May 18, 2005, Recall # Z-0805-05, the recall product is the CM 100-Headstart Adapter Cable, Cat. No. 920650 (not Laerdal Medical Corp, CM 100-HeadStart® Automatic External Defibrillator Adapter Cables). The recalled Adapter Cables are for use with the Laerdal Heartstart 4000 and various Philips models listed. The Laerdal Heartstart 3000 is not involved or affected by this recall. It should not be included. The subject Adapter Cable cannot be attached to a Heartstart 3000. Customers are instructed to discontinue use of the Adapter Cables, and to order alternative cabled electrodes that do not require adapters (not alternative cables) from Philips Medical Systems. The recalling firm is Laerdal Medical, not Volex Inc., and Laerdal’s firm initiated recall is ongoing.
CLASS II
MANUFACTURER: Recalling Firm: Spinal Specialties, Inc., San Antonio, TX, by letter on April 15, 2005. Manufacturer: Becton Dickinson & Co, Franklin Lakes, NJ. Firm initiated recall is ongoing.
PRODUCT: a) Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.: 4043. Recall # Z-0885-05; b) 22G Nerve Block PainPak, Reorder No.: 3269. Recall # Z-0886-05.
REASON: Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letters on November 17, 2003. Firm initiated recall is complete.
PRODUCT: LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Recall # Z-0887-05.
REASON: A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
MANUFACTURER: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on April 21, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Hitachi Altaire Magnetic Resonance Imaging Device. Recall # Z-0888-05; b) Hitachi AIRIS II Magnetic Resonance Imaging Device. Recall # Z-0889-05; c) Hitachi AIRIS Elite Magnetic Resonance Imaging Device. Recall # Z-0890-05.
REASON: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
MANUFACTURER: Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., St. Paul, MN, by telephone and recall notice, dated May 31, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Recall # Z-0891-05; b) Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Product derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Recall # Z-0892-05.
REASON: Device is contained in 2 pouches. The outer pouch’s seal may be compromised; this may render the exterior of the interior pouch non-sterile.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 15, 2005:
CLASS II
MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by letter on May 2, 2005. Firm initiated recall is ongoing.
PRODUCT: Nichols Advantage Sample hGH Diluent Set, Catalog No. 62-7756. Recall # Z-0873-05.
REASON: Under recovery of diluted samples by as much as 20%.
MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by letter on April 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Nichols Advantage TSH -- Third Generation. Recall # Z-0874-05.
REASON: Does not meet performance claims in the labeling for analytical and functional sensitivity.
MANUFACTURER: Recalling Firm: Liko, Inc, Franklin, MA, by letter dated September 29, 2004. Manufacturer: Liko Ab, Lulea, Sweden. Firm Initiated recall is ongoing.
PRODUCT: a) UNO 102 EM/EE/ES Patient Lift. Recall # Z-0875-05; b) UNO 100 EM/EE Patient Lift. Recall # Z-0876-05; c) Sabina I and II EM/EE Patient Lift. Recall # Z-0877-05.
REASON: Incorrect length support screws may cause patient lift failure.
MANUFACTURER: Recalling Firm: Maquet Inc, Bridgewater, NJ, by letter on March 31, 2005. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
PRODUCT: Servo-I Ventilator. Recall # Z-0878-05.
REASON: Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
MANUFACTURER: Recalling Firm: Perkin Elmer Life and Analytical, North Billerica, MA, by letter on March 11, 2005 and May 5, 2005. Manufacturer: Perkin Elmer Life Sciences, Turku, Finland. Firm initiated recall is ongoing.
PRODUCT: Perkin ELmer Life and Analytical Sciences - NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit. Recall # Z-0879-05.
REASON: Pump failure may affect data integrity.
MANUFACTURER: Spinal Concepts, Inc, An Abbott Laboratories Company, Austin, TX, by telephone around August 2002. Firm initiated recall is complete.
PRODUCT: SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System. Recall # Z-0880-05.
REASON: Complaints were received where swivels came out of plate and where the screw went through the plate.
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 18, 2005. Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: a) Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. Recall # Z-0881-05; b) Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. Recall # Z-0882-05; c) Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001. Recall # Z-0883-5.
REASON: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
CLASS III
MANUFACTURER: International Remote Imaging Systems Inc, Chatsworth, CA, by telephone on April 29, 2005. Firm initiated recall is ongoing.
PRODUCT: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. Recall # Z-0884-05.
REASON: Nonconformance to performance specifications. The instrument failed to report a positive result for nitrite which was expected for a conforming part B control.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 8, 2005:
CLASS II
MANUFACTURER: Arrow International Inc., Reading, PA, by letter on/about February 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Arrow Continuous Nerve Block Needle, Latex-Free, Rx only, Sterile. Recall # Z-0852-05.
REASON: Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 3, 2005. Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
PRODUCT: a) Baxter PosiFlow Access Device for IV Access; PRODUCT code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. Recall # Z-0853-05; b) Baxter Extension Sets with PosiFlow Access Device for IV Access; Product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with PosiFlow Positive Displacement Feature. Recall # Z-0854-05.
REASON: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
MANUFACTURER: Arizant Inc., Eden Prairie, MN, by letters beginning March 11, 2005. Firm initiated recall is ongoing.
PRODUCT: Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature management unit. Not sterile. Do not use I f primary packaging has been previously opened or is damaged. Recall # Z-0855-05.
REASON: Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
MANUFACTURER: Recalling Firm: Wahl Clipper Corp, Sterling, IL, by a Stop Sales notice on/or about December 10, 2004. Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China. Firm initiated recall is ongoing.
PRODUCT: Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Model Number 4196-1. The model number and date code are molded into the side of the handle of the massager near the on/off switch. Recall # Z-0856-05.
REASON: The housing of the massager's heating applicator attachment may crack during use. If the plastic housing cracks and breaks it could expose the user to live electrical connections and pose a shock hazard.
MANUFACTURER: Cryolife, Inc, Kennesaw, GA, by telephone on May 17, 2005. Firm initiated recall is complete.
PRODUCT: a) Aortic Valve & Conduit, Donor #77647, Model #AV00. Recall # Z-0859-05; b) Pulmonary Valve & Conduit. Donor #77647, Model #PV00. Recall # Z-0860-05.
REASON: Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
MANUFACTURER: Zimmer Inc., Warsaw, IN, by email on February 9, 2005. Firm initiated recall is ongoing.
PRODUCT: Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10. Recall # Z-0864-05.
REASON: The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is longer than will fit.
MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by letter on May 6, 2005. Firm initiated recall is ongoing.
PRODUCT: Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01). Recall # Z-0865-05.
REASON: The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated April 18, 2005. Firm initiated recall is complete.
PRODUCT: VITROS VALP Reagent, REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Recall # Z-0866-05.
REASON: Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letter on/about May 16, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 7.0mm Product Number: 535070. Recall # Z-0867-05; b) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080. Recall # Z-0868-05; c) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 9.0mm Product Number: 535090. Recall # Z-0869-05; d) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 7.0mm Product Number: 538070E. Recall # Z-0870-05; e) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 538080E. Recall # Z-0871-05; f) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 9.0mm Product Number: 538090E. Recall # Z-0872-05.
REASON: Guiding catheter may have thinner and weaker sidewalls than designed, and may break. CLASS III MANUFACTURER: Recalling Firm: Mick Radio Nuclear Instruments, Inc., Mount Vernon, NY, by letters on March 30, 2005, and telephone on April 22, 2005. Manufacturer: Manan Medical Products, Inc., Wheeling, IL. Firm initiated recall is ongoing. PRODUCT: Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- Brand Name: Mick TP Disposable Needle 18 Gauge. Common/Usual Name: TP Needle 18 Gauge. Classification Name: System, Applicator, Radionuclide, Manual. The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each. Recall # Z-0857-05. REASON: Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator.
MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by telephone on May 5, 2005, May 12, 2005 and by letter on May 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x 1", Catalog Number: 4238. Recall # Z-0858-05.
REASON: Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8".
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 1, 2005:
CLASS II
MANUFACTURER: Darex Container Products, Division of W.R. Grace & Co., Chicago, IL, by letters dated March 30, 2005. Firm initiated recall is ongoing.
PRODUCT: Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails. Recall # Z-0850-05.
REASON: Both lots were found to be out of specification due to an elevated level of small particles (fines).
MANUFACTURER: Recalling Firm: Inamed Corp, Goleta, CA, by letter on May 5, 2005 and follow-up telephone calls. Manufacturer: McGhan Medico, SA, Barreal de Heredia, Costa Rica. Firm initiated recall is ongoing.
PRODUCT: Style 363 Saline-Filled BIOCELL textured Breast Implants. Recall # Z-0851-05.
REASON: Wrong size Implant was mislabeled with the wrong size.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 25, 2005:
CLASS I
MANUFACTURER: Lifescan Inc, Milpitas, CA, by letters on April 11, 2005. Firm initiated recall is ongoing.
PRODUCT: a) LifeScan brand OneTouch Ultra Blood Glucose Meter. Recall # Z-0821-05; b) LifeScan brand OneTouch FastTake Blood Glucose Meter. Recall # Z-0822-05; c) LifeScan brand InDuo Blood Glucose Meter. Recall # Z-0823-05;
REASON: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
MANUFACTURER: Biomerieux, Inc, Durham, NC, by letter on/about March 7, 2005. Firm initiated recall is ongoing.
PRODUCT: Simplastin HTFÆ Reagents, 20ml H2O, (and 6 ml H2O). Product numbers 259846, 259847. Recall # Z-0843-05.
REASON: The ISI labeling for SimplastinÆ HTF on the Coag-a-MateÆ MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
CLASS II
MANUFACTURER: AMF Support Surfaces, Inc., Corona, CA, by letters dated January 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress). Recall # Z-0844-05.
REASON: Operator misconnected device power cords causing failure of the device.
MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL, by letters dated February 28, 2005. Manufacturer: Baxter Healthcare, Corp. of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
PRODUCT: Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Recall # Z-0845-05.
REASON: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
MANUFACTURER: Hitachi Medical Systems America, Inc., Twinsburg, OH, by site inspections beginning on November 19, 2004. Firm initiated recall is ongoing.
PRODUCT: Altaire, Magnetic Resonance Imaging Device. Recall # Z-0846-05.
REASON: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letters on April 21, 2005. Manufacturer: Ciba Vision Corp., Des Plaines, IL. Firm initiated recall is ongoing.
PRODUCT: Fresh Look * Radianceô * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * The product has been distributed in twin packs containing six pairs of lenses. Recall # Z-0847-05.
REASON: The actual power of the lenses may be different from what is indicated on the package labeling.
MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on May 2, 2005. Firm initiated recall is ongoing.
PRODUCT: Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05.
REASON: The device may disarm and not deliver shock when performing a Synchronized Cardioversion.
MANUFACTURER: Edwards Lifesciences Llc, Irvine, CA, by voice mail and letters on April 28, 2005 and May 2, 2005. Firm initiated recall is ongoing.
PRODUCT: Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D). Recall # Z-0849-05.
REASON: Potential for deployment difficulties.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 18, 2005:
CLASS I
MANUFACTURER: Recalling Firm: Laerdal Medical Corporation, Wappingers Falls, NY, by press release on April 28, 2005, and by letters on April 29, 2005.
Manufacturer: Volex Inc., North Dartmouth, MA. Firm initiated recall is ongoing.
PRODUCT: LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads "PART # 920650 ADAPTER CM100/LMC ELECTRODE". There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack. Recall # Z-0805-05.
REASON: Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
MANUFACTURER: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by letters dated April 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part number 972200E. Recall # Z-0806-05.
REASON: The Welch Allyn AED 20 product may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.
CLASS II
MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters beginning March 25, 2005.
Manufacturer: Medtronic Mexico, S. De R.L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing. PRODUCT: Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Label reads: Manufacturer: Medtronic, Inc. Minneapolis, MN. Recall # Z-0808-05.
REASON: Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly and had been sterilized, the ruptured seal breaches the sterility barrier for the package.
MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letters on March 9 and ll, 2005. Firm initiated recall is ongoing.
PRODUCT: Nichols IRMA Intact PTH Assay, catalog No. 40-2171. Recall # Z-0809-05.
REASON: Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letters dated March 25, 2005. Firm initiated recall is ongoing.
PRODUCT: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040. Recall # Z-0810-05.
REASON: Values do not agree with Directional Instructions (DI). Lot 62-402598's results were outside the DI claim for functional sensitivity, reproducibility, parallelism and two interfering substances. Lot 62-402622's results were outside the DI claim for functional sensitivity, reproducibility, recovery, parallelism and two interfering substances.
MANUFACTURER: Recalling Firm: Heartport, Inc., Somerville, NJ, by telephone on April 8, 2005. Manufacturer: MedSource Technologies-Laconia, Laconia, NH. Firm initiated recall is ongoing.
PRODUCT: The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Product Code EC1001. Recall # Z-0811-05.
REASON: Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.
MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on July 12, 2004. Firm initiated recall is ongoing.
PRODUCT: a) ENTrak Navigation and Visualization System. Recall # Z-0812-05; b) ENTrak Plus Navigation and Visualization System. Recall # Z-0813-05; c) InstaTrak 3500 Navigation and Visualization System. Recall # Z-0814-05; d) InstaTrak 3500 Plus Navigation and Visualization System. Recall # Z-0815-05;
REASON: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letters dated March 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Tube Stand for the Dynarad Phantom Mobile X-Ray System. Catalog #501031. Recall # Z-0816-05.
REASON: The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
MANUFACTURER: Eastman Kodak Co., Rochester, NY, by letters on April 8, 2005. Firm initiated recall is ongoing.
PRODUCT: KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak Direct View CR 500 systems. Screens are sold in the following sizes and Cat. No's: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm. Recall # Z-0817-05.
REASON: Screens may be affected with image artifacts.
MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on April 1, 2005. Firm initiated recall is ongoing.
PRODUCT: Axiom Artis MP X-Ray System. Recall # Z-0818-05.
REASON: Potential problem with the fluoroscopy switch on the power grip.
MANUFACTURER: CTI PET Systems Inc., Knoxville, TN, by letters beginning April 5, 2005. Firm initiated recall is ongoing.
PRODUCT: ECAT PET Scanners (mobile systems), Reveal XL (mobile systems), and Sceptre and Sceptre XL (mobile systems). Recall # Z-0819-05.
REASON: Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
MANUFACTURER: Kingswood Laboratories, Inc., Indianapolis, IN, by press release and letter dated April 22, 2005. Firm initiated recall is ongoing.
PRODUCT: Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, Contents: 3 fibre-tipped swabsticks premoistened with Moi-Stir mouth moistening solution and saliva supplement; Product No's. 55299-703-03 and 55299-703-25. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 fail packs to the case. Recall # Z-0820-05
REASON: Contaminated with Aspergillus and Penicillum molds.
MANUFACTURER: Dunlee, Aurora, IL, by letters dated April 4, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Model DA 200 and MX200, Part number 875-01; Recall # Z-0838-05; b) Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube housing assemblies; Model DA 200 PRO and MX200 PRO, part number 875-01. Recall # Z-0839-05; c) Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Model DA 200 Ultra and MX200 Ultra, Part number 875-01. Recall # Z-0840-05.
REASON: The X-ray tube housing assembly may have been mounted with the incorrect sized bolts.
MANUFACTURER: Medrad, Inc., Indianola, PA, by letter dated March 9, 2005. Firm initiated recall is ongoing
PRODUCT: Continuum MR Compatible Infusion Pump. Pump Model #3009135. Recall # Z-0841-05.
REASON: Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket
MANUFACTURER: Arrow International, Inc., Reading, PA, by letter beginning on March 23, 2005. Firm initiated recall is ongoing.
PRODUCT: The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit. Recall # Z-0842-05. REASON: The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use. CLASS III MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, on September 24, 2004. Manufacturer: Polymedco, Inc., Cortlandt Manor, NY. Firm initiated recall is ongoing. PRODUCT: Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.
REASON: A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the "refresh button" has not been pressed. The graph may appear valid; however erroneous results may occur.
MANUFACTURER: Smiths Medical PM, Inc, Waukesha, WI, by e-mail on March 16, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225. Recall # Z-0824-05; b) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335. Recall # Z-0825-05; c) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325. Recall # Z-0826-05; d) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325. Recall # Z-0827-05; e) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325. Recall # Z-0828-05; f) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220. Recall # Z-0829-05; g) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325. Recall # Z-0830-05; h) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320. Recall # Z-0831-05; i) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335. Recall # Z-0832-05; j) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335. Recall # Z-0833-05; k) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325. Recall # Z-0834-05; l) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325. Recall # Z-0835-05.
REASON: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
MANUFACTURER: Tri-State Hospital Supply Corp, Howell, MI, by letter dated April 12, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Centurion brand CirClamp with 1.3 cm bell, sterile, single use: product 330. Recall # Z-0836-05; b) Centurion brand CirClamp with1.1 cm bell, sterile, single use; product 310. Recall # Z-0837-05.
REASON: Lot 11224 of product 330 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 11, 2005:
CLASS II
MANUFACTURER: Sunrise Medical, Inc., Longmont, CO, by telephone and letters, dated February 3, 2005. Firm initiated recall is ongoing.
PRODUCT: Sunrise Hoyer Advance Hydraulic and battery powered Patient lifts. a) Model: Hoy-Advance-E; b) Model: Hoy-Advance-H. Recall # Z-0785-05.
REASON: The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.
MANUFACTURER: Fisher Imaging Corporation, Denver, CO, by letters on September 30, 2004. Firm initiated recall is ongoing.
PRODUCT: VersaRad Generator. Recall # Z-0787-05.
REASON: Some VersaRad Systems have a faulty weld that may result in oil leakage.
MANUFACTURER: Asahi Medical Co. Ltd, Chiyoda Ku, Japan, by letters dated March 30 and 31, 2005, April 8, April 13, and 14, 2005 and April 21, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6426, Model AM-BIO-65 ‚ 1.3 m2 surface area, Schein product code 629-3146, Model AM-BIO-75 ‚ 1.5 m2 surface area, Schein product code 629-0041, Model AM-BIO-100 ‚ 2.0 m2 surface area. Recall # Z-0788-05; b) Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6404,Model AM-BIO-HX-75 ‚ 1.5 m2 surface area and Schein product code 629-8540, Model AM-BIO-HX-100 ‚ 2.0 m2 surface area. Recall # Z-0789-05; c) Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product CODE 629-4923, Model APS-21R - 2.1 m2 surface area. Recall # Z-0790-05; d) Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-9041, Model CL*E12NLA - 1.2 m2 surface area, Schein product code 629-5978, Model CL*E15NLA ‚ 1.5 m2 surface area, Schein product code 629-1824, Model CL*E18NLA - 1.8 m2 surface area and Schein product code 629-7278, Model CL*E20NLA ‚ 2.0 m2 surface area. Recall # Z-0791-05; e) Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-3169, Model CL*EE12NLA - 1.2 m2 surface area, Schein product code 629-8232, Model CL*EE15NLA ‚ 1.5 m2 surface area and Schein product code 629-5106, Model CL*EE20NLA - 2.0 m2 surface area. Recall # Z-0792-05.
REASON: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
MANUFACTURER: Stryker Medical, Kalamazoo, MI, by letter dated March 31, 2005. Firm initiated recall is complete.
PRODUCT: Stryker brand Birthing Bed; Model 4701. Recall # Z-0793-05.
REASON: Trendelenburg and reverse trendelenburg features may not function.
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated March 24, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
PRODUCT: Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05.
REASON: Live display in exam room may sporadically stop working although the display in the control room remains fully operational.
MANUFACTURER: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter, dated April 11, 2005. Firm initiated recall is ongoing.
PRODUCT: Altaire, Magnetic Resonance Imaging Device. Recall # Z-0797-05.
REASON: The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
MANUFACTURER: Recalling Firm: Selectivemed Components, Inc., Mount Vernon, OH, by letter, dated March 15, 2005. Manufacturer: MRP, Inc., Monticello, IN. Firm initiated recall is ongoing.
PRODUCT: Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments. Recall # Z-0799-05.
REASON: The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters, dated March 28, 2005. Manufacturer: Baxter Healthcare Corp., Cleveland, MI. Firm initiated recall is ongoing.
PRODUCT: Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25 G x 8.9 cm (3-1/2î) Whitacre Spinal Needles. Recall # Z-0800-05.
REASON: The anesthesia trays contain BD 25G Spinal Needles which have leakage at the plastic hub of the needle.
MANUFACTURER: Ela Medical Llc, Plymouth MN, by letter, on January 25, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. Recall # Z-0801-05; b) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. Recall # Z-0802-05.
REASON: A change in the automatic capacitor reform schedule during the later portion of the deviceIs useful life can result in excessive 750V charge times and disable the deviceIs ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.
MANUFACTURER: Recalling Firm: Frank Mobility Systems, Inc., Oakdale, PA, by letter on September 1, 2004. Manufacturer: Ulrich-Alber Gmbh, Albstadt Tailfingen, Germany. Firm initiated recall is ongoing.
PRODUCT: a) e-fix E19 power drive. The product is a wheelchair component/accessory. Recall # Z-0803-05; b) e-fix E20 power drive. The product is a wheelchair component/accessory. Recall # Z-0804-05.
REASON: Product may short circuit within the interface due to long term exposure of liquid. CLASS III
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by telephone and Urgent Product Recall Notice on February 8, 2005. Firm initiated recall is ongoing.
PRODUCT: Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000. Recall # Z-0786-05.
REASON: The device has the potential to overheat and cause patient burns during use. MANUFACTURER: Recalling Firm: U.S. Filter/Ionpure, Inc., Lowell, MA, by letter between March 17, and March 28, 2005.
Manufacturer: U.S. Filter Water Process Inc, Colorado Springs, CO. Firm initiated recall is ongoing.
PRODUCT: MedRo Rx ‚ Reverse Osmosis System All Models All Voltages. Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08. Recall # Z-0798-05.
REASON: Incorrect type of stainless steel firm used 303 vs 316.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 4, 2005:
CLASS II MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery, Cincinnati, OH, by letters,dated December 14, 2004. Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) Endopath 5 mm Graspers with Ratchet Handles(product code5DSG). Recall # Z-0724-05; b) Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB). Recall # Z-0725-05; c) Endopath 10 mm Anvil Graspers with Ratchet Handles (product code 10AG). Recall # Z-0726-05; d) Endopath 10 mm Babcocks with Ratchet Handles (product code 10BB). Recall # Z-0727-05; e) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC21. Recall # Z-0728-05; f) FlexTrayTM EndopathÆ Cholecsystectomy Tray, CK141. Recall # Z-0729-05; g) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC24. Recall # Z-0730-05; h) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW22. Recall # Z-0731-05; i) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW42. Recall # Z-0732-05; j) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW46. Recall # Z-0733-05; k) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW49; Recall # Z-0734-05; l) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW71S. Recall # Z-0735-05; m) FlexTrayTM EndopathÆ GYN Tray, Kit code KD005. Recall # Z-0736-05; n) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG05. Recall # Z-0737-05; o) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG15. Recall # Z-0738-05; p) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB12. Recall # Z-0739-05; q) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB19. Recall # Z-0740-05; r) FlexTrayTM EndopathÆ Gastric Tray, Kit code KNG05. Recall # Z-0741-05; s) FlexTrayTM EndopathÆ Bariatric Tray, Kit code TBW70S. Recall # Z-0742-05; t) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC09. Recall # Z-0743-05; u) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC45. Recall # Z-0744-05; v) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC78S. Recall # Z-0745-05; w) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC86S. Recall # Z-0746-05; x) FlexTrayTM EndopathÆ Gastric Tray, Kit code TGB01S. Recall # Z-0747-05; y) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL45. Recall # Z-0748-05; z) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL62. Recall # Z-0749-05; aa) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC06. Recall # Z-0750-05; bb) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC12. Recall # Z-0751-05; cc) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC15. Recall # Z-0752-05; dd) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC20. Recall # Z-0753-05; ee) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC61. Recall # Z-0754-05; ff) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC69. Recall # Z-0755-05; gg) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG42. Recall # Z-0756-05; hh) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG73. Recall # Z-0757-05; ii) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG89. Recall # Z-0758-05; jj) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW30. Recall # Z-0759-05.
REASON: Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
MANUFACTURER: Recalling Firm: MMS Sales Corp, Pharr, TX, by letter on February 21, 2004.Manufacturer: CPM De Reynosa S.A. De C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) Meridian Nexus, single use. Part Numbers: C4N00D001,15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301- 13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Recall # Z-0760-05; b) Circuit-Unilimb, Pediatric, 1M (40"), Disposable, Clean Non-Sterile, Pediatric Anethesia Circuit, Part Number DYNJAPF4000. Recall # Z-0761-05; c) Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Recall # Z-0762-05; d) Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Recall # Z-0763-05; e) Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Recall # Z-0764-05; f) Circuit- Maching Kit, 40" Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Recall # Z-0765-05; g) Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Recall # Z-0766-05; h) Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Recall # Z-0767-05; i) Circuit-Unilimb, Adult, 1M (40"), Disposable, Clean Non-sterile, Adult Anesthesia Circuit, Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261. Recall # Z-0768-05.
REASON: Partial occlusion in the T-piece resulting in airway obstruction.
MANUFACTURER: Medline Industries, Inc, Waukegan, IL, by letters dated March 18, 2005 and March 23, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Recall # Z-0769-05; b) Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF6267; the kit contains the Nexus Adult Unilimb Circuit -- 60", part 60010-1B, along with a 3 liter latex breathing bag, anesthesia tubing clip, suction catheter, adult anesthesia mask, suction canister, drawstring poly bag and poly bag. Recall # Z-0770-05; c) Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia mask, suction tubing, humid vent hme filter and poly bag. Recall # Z-0771-05; d) Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N000D001, along with a 3 liter latex free breathing bag, adult medium anesthesia mask and poly bag. Recall # Z-0772-05; e) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N012100, along with a 3 liter latex free breathing bag, gas sampling coestrud and poly bag. Recall # Z-0773-05; f) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag. Recall # Z-0774-05.
REASON: The procedure packs contain anesthesia/breathing circuits being recalled due to partial occlusion of the T-piece resulting in airway obstruction.
MANUFACTURER: Staar Surgical Co, Inc, Monrovia, CA, by telephone and letter on April 7,2004. Firm initiated recall is ongoing.
PRODUCT: Staar Phaco Tubing Kit. Recall # Z-0775-05.
REASON: Complaints of leaking with question of sterility and risk of infection in eye.
MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letters on February 4, 2005. Firm initiated recall is ongoing.
PRODUCT: Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability. Recall # Z-0777-05.
REASON: Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
MANUFACTURER: Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter dated March 16, 2005. Manufacturer: Johnson & Johnson Medical, Ltd, Skipton, North Yorkshire, UK. Firm initiated recall is ongoing.
PRODUCT: Cidexplus Solution Test Strips. Product Code: 2924, and Product Code2926. Recall # Z-0779-05.
REASON: CIDEX test strips were found to pass solution below MEC.
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letters on March 11, 2005. Manufacturer: Boston Scientific Corp., Glens Falls, NY. Firm initiated recall is ongoing.
PRODUCT: a) Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. Recall # Z-0780-05; b) Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. Catalog No. 45-236, Ref. # M001452360. Recall # Z-0781-05; c) Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. Recall # Z-0782-05.
REASON: Potential separation of the port base from the port cover after implantation.
MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by e-mail on March 11, 2005. Firm initiated recall is ongoing.
PRODUCT: Architect Folate Reagent Kit, list 6C12-20 (4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests). Recall # Z-0783-05.
REASON: Concentrations for normal samples generated with current reagent lots of the Architect Folate assay are lower than data generated for the package insert.
CLASS III
MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, fax or email beginning April 8, 2005.
Manufacturer: DiaSorin S.p.A. Saluggia, Italy. Firm initiated recall is ongoing.
PRODUCT: DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Recall # Z-0776-05.
REASON: The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 2, 2005. Manufacturer: Valcom, Inc, Las Vegas, NV. Firm initiated recall is ongoing.
PRODUCT: Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155. Recall # Z-0778-05.
REASON: The Configuration Transfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it, not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.
MANUFACTURER: Recalling Firm: Diasorin, Inc., Stillwater, MN, by telephone and e-mail on March 16, 2005. Firm initiated recall is ongoing. Manufacturer: Phoenix Bio-Tech Corp., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
PRODUCT: Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960. Recall # Z-0784-05.
REASON: Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 27, 2005:
CLASS II
MANUFACTURER: Fischer Imaging Corporation, Denver , CO , by letter on January 13, 2005. Firm initiated recall is ongoing.
PRODUCT: Bloom DTU-215-B Programmable Stimulator. Recall # Z-0713-05.
REASON: Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
MANUFACTURER: Bard Access Systems, Inc., Salt Lake City, UT , by letter on October 4, 2004 and October 15, 2004. Firm initiated recall is complete.
PRODUCT: a) Site-Rite Sterile Needle Guide Kit – 18 gauge. Product Code 9001C0212. Recall # Z-0714-05; b) Site-Rite Sterile Needle Guide Kit – 20 gauge. Product Code 9001C0214. Recall # Z-0715-05; c) Site-Rite Sterile Needle Guide Kit – 21 gauge. Product Code 90013B01. Recall # Z-0716-05; d) Site-Rite Sterile Ultrasound Probe Cover with Gel. Product Code 9001C0197. Recall # Z-0717-05; e) Intraoperative Ultrasound Cover Kit. Product Code 900023B01. Recall # Z-0718-05; f) Ultra/Phonic Conductivity Gel, 20 ml, each unit is an oil to foil pouch. Product is packaged 25 pouches per box. Product Code 9001C0200. Recall # Z-0719-05. g) Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. Recall # Z-0720-05.
REASON: Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett, Pleasanton , CA , by letters on December 3, 2004 . Manufacturer: MMJ S.A. De C.V., Cuidad Juarez, Mexico. Firm initiated recall is complete.
PRODUCT: Shiley FlexTra brand Flexible Dual- Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed. Recall # Z-0721-05.
REASON: Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
MANUFACTURER: Allen Medical Systems, Acton, MA, by letter dated March 4, 2005. Firm initiated recall is ongoing.
PRODUCT: Allen A-91000 Shoulder Positioner. Recall # Z-0722-05.
REASON: Shoulder positioner may break near the rail that attaches to the operating table.
MANUFACTURER: Intuitive Surgical, Inc, Sunnyvale , CA , by letters on March 9, 2005 . Firm initiated recall is ongoing.
PRODUCT: Intuitive Surgical da Vinci 8 mm Endo Wrist Curved Scissors, in box. FDA Device Listing # R100529, Model # 400178-01. 510(k) number K021036. Recall # Z-0723-05.
REASON: Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
CLASS III
MANUFACTURER: Tri-State Hospital Supply Corp., Howell, MI, by letter dated March 8, 2005. Firm initiated recall is ongoing.
PRODUCT: Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHNO10S. Recall # Z-0696-05.
REASON: Some of the needles in these sets are ¾ inches in length instead of the labeled 1 inch.
MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letters on December 1, 2004 . Firm initiated recall is ongoing.
PRODUCT: Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05.
REASON: The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the Pro- Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
MANUFACTURER: Diasorin , Inc., Stillwater , MN , by telephone on May 20, 2004 . Firm initiated recall is ongoing.
PRODUCT: Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05.
REASON: When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model Elx50, the software did not automatically clear old versions of the wash program when new ones were added.
MANUFACTURER: Diagnostic Systems Laboratories, Inc., Webster, TX. Firm initiated recall is ongoing. Recalling Firm: Diasorin, Inc., Stillwater , MN , by letters on May 25, 2004 .
PRODUCT: DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Recall # Z-0704-05.
REASON: Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.
PRODUCT: DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. Recall # Z-0705-05.
REASON: An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.
PRODUCT: DiaSorin Analyte Specific Reagent. Recall # Z-0706-05.
REASON: Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
MANUFACTURER: Trek Diagnostic Systems, Inc., Sun Prairie, WI. Firm initiated recall is ongoing.
PRODUCT: Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. Recall # Z-0708-05.
REASON: Blood culture bottles with an error in the bar code on the labels, were shipped.
MANUFACTURER: Porex Surgical, Inc., Newnan , GA , by email, telephone and letter on March 7, 2005 and March 8, 2005 . Firm initiated recall is ongoing.
PRODUCT: MEDPOR® Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 *. Recall # Z-0712-05.
REASON : The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 20, 2005:
CLASS II
MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 13, 2004. Firm initiated recall is ongoing
PRODUCT: a) ENTrak Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0687-05; b) ENTrak Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0688-05; c) Insta Trak 3000 Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0689-05; d) Insta Trak 3500 Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0690-05; e) Insta Trak 3500 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0691-05; - 2 - f) Fluro Trak 9800 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0690-05;
REASON: Enhanced sterility testing revealed the sterilization efficacy of accessories (“Sensors”) used with certain Navigation and Visualization systems may be compromised.
MANUFACTURER: Manufacturer: Baxter Healthcare Corp, Aibonito, PR. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated January 20, 2005
PRODUCT: a) Baxter Posiflow Access Device for IV Access; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. Recall # Z-0693-05; b) Baxter Extension Sets with Posiflow Access Device for IV Access; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature. Recall # Z-0694-05.
REASON: Product older than three years may not operate as intended
MANUFACTURER: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing. Recalling Firm: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on January 31, 2005.
PRODUCT: Easy Access Image Management System with CL. Net. Recall # Z-0695-05.
REASON: Failure to update correctly when re-transmitting an image from the modality.
MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by letter on February 15, 2005. Firm initiated recall is ongoing.
PRODUCT: Automatic Cutting Needle Model: NAC-1820B, Size 18 GA x 20 CM, Single use: Ethylene Oxide sterilized. Recall # Z-0697-05.
REASON: The stylet hub detaches from the stylet needle.
MANUFACTURER: Wilson-Cook Medical, Inc., Winston Salem, NC, by letter on April 1, 2005. Firm initiated recall is ongoing.
PRODUCT: a) ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew - Right Device: Flexible TI - Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI - Knot Quickload Units (2) * Disposable - Single Use Only * Sterile/EO * Rx Only. Recall # Z-0698-05; b) BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable – Single Use Only * Sterile/EO * Rx Only * Recall # Z-0699-05.
REASON: The expiration date listed on the product label is greater than the vendor recommended expiration date.
MANUFACTURER: Neoprobe Corp, Dublin, OH, by telephone and e-mail beginning on December 2, 2004. Firm initiated recall is ongoing.
PRODUCT: a) CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0700-05; b) CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0701-05.
REASON: The probe’s faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
MANUFACTURER: Guidant Corporation Advanced Cardiovascular System, Temecula, CA, by letter on January 27, 2005. Firm initiated recall is ongoing.
PRODUCT: Voyager RX Coronary Dilatation Catheter. Recall # Z-0707-05.
REASON: Leak at guide wire exit notch could introduce air into the artery.
MANUFACTURER: St. Jude Medical, Sylmar, CA, by visit beginning on March 10, 2005. Firm initiated recall is ongoing
PRODUCT: Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343. Recall # Z-0709-05.
REASON: Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery
MANUFACTURER: Maquet, Inc., Bridgewater, NJ, by internal task team, updates started on January 11, 2005. Firm initiated recall is ongoing.
PRODUCT: KION Anesthesia System. Recall # Z-0710-05.
REASON: Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
MANUFACTURER: Medtronic Surgical Navigation Technologies, Inc., Louisville, CO, by letters dated January 28, 2005 and February 2, 2005. Firm initiated recall is complete.
PRODUCT: Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05.
REASON: The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make visible supplemental contours of specific anatomy viewable during a surgical procedure. Activation of a new tip extension feature will move the location of these contours in such a manner that they no longer correlate to the intended anatomy. Potential consequences may include improper resection of the brain tissue.
MANUFACTURER: Diasorin Inc., Stillwater, MN, by telephone on November 1, 2004. Firm initiated recall is ongoing.
PRODUCT: DiaSorin ETI-EA-G assay kit, Catalog No. 7570. Recall # Z-0658-05.
REASON: The kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the Pro Trac II Tacrolimus kit.
MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter on February 25, 2005. Firm initiated recall is ongoing.
PRODUCT: IMx HAVAB Controls in Vitro Test. Recall # Z-0660-05.
REASON: Abbott identified through investigational studies that IMxHAVAB Controls is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 20, 2004. Firm initiated recall is ongoing.
PRODUCT: DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05.
REASON: An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.
PRODUCT: Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05.
REASON: The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on October 26, 2004. Firm initiated recall is ongoing
PRODUCT: Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05.
REASON: The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing
PRODUCT: Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05.
REASON: The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone and letter on June 30, 2004. Firm initiated recall is ongoing.
PRODUCT: PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05.
REASON: The program is for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160
MANUFACTURER: The Spineology Group, Stillwater, MN, by product update on January 28, 2005 and by telephone between January 28 and January 31, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Fill Tube, diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology’s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0677-05; b) Fill Tube, straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology's OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0678-05; c) Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0679-05;
REASON: Three malfunctions, due to jamming of bone material in the fill tube occurred. Fill tubes are used in delivery of bone graft materials.
MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letter on December 2, 2004. Firm initiated recall is ongoing.
PRODUCT: CryoValve, Aortic Valve and Conduit. Donor #56844, Model #AV00. Recall # Z-0686-05.
REASON: An incorrect lot number was entered in the production record for the solution in which this allograft was packaged
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 13, 2005:
CLASS I
MANUFACTURER: Dade Behring Inc, West Sacramento, CA, by letters on January 27, 2005 and February 10, 2005. Firm initiated recall is ongoing.
PRODUCT: MicroScan Ô Rapid Pos Inoculum Broth, Catalog #: B1015-14. Recall # Z-0668-05.
REASON: There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
CLASS II
MANUFACTURER: CTI PET Systems, Inc, Knoxville, TN, by letter on May 27, 2004. Firm initiated recall is ongoing.
PRODUCT: PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: • Siemens Models: Biograph PET/CT • CTI Models: Reveal PET/CT. Recall # Z-0547-05.
REASON: Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.
MANUFACTURER: Cryolife Inc., Kennesaw, GA, by letter on January 12, 2005. Firm initiated recall is complete.
PRODUCT: CryoValve, Pulmonary Valve and Conduit. Donor Number: 70022, Model Number: PV00. Recall # Z-0669-05.
REASON: During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
MANUFACTURER: Cincinnati Sub-Zero Products, Cincinnati, OH, by letter dated January 18, 2005. Firm initiated recall is ongoing.
PRODUCT: Electri-Cool II. Recall # Z-0670-05.
REASON: There is the potential that the power switch assembly can dislodge from the cabinet during use.
MANUFACTURER: Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated January 18, 2005. Firm initiated recall is ongoing.
PRODUCT: Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05.
REASON: There is the potential that the power switch assembly can dislodge from the cabinet during use.
MANUFACTURER: Hudson RCI Tecate S. de R.L. de C.V., Mexico. Firm initiated recall is ongoing. Recalling Firm: Teleflex Medical, Bannockburn, IL, by letter on February 23, 2005.
PRODUCT: a) Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; sold under the following catalog numbers: • catalog number (REF) V5-16037: Novaplus Sterile Sher-I- Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, • catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr. Recall # Z-0680-05; b) Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; catalog number (REF) 5-16137. Recall # Z-0681-05.
REASON: The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating "Bronchial - Right" instead of "Bronchial - Left", and catalog number 5-16137 stating "Bronchial - Left" instead of "Bronchial - Right".
MANUFACTURER: Hitachi Medical Systems, CT Product Division, Kashiwa, Japan. Firm initiated recall is ongoing. Recalling Firm: Philips Medical Systems Sales and Service, Region No. America, Bothell, WA, by on site visit, beginning on February 10, 2005.
PRODUCT: Tomoscan. Recall # Z-0682-05.
REASON: Potential for shift of reference lines.
MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letters dated December 17, 2004, January 3, 2005, and January 19, 2005. Firm initiated recall is ongoing.
PRODUCT: a) CryoValve, Aortic Valve & Conduit SG. Donor #63601, Model #SGAV00. Recall # Z-0683-05; b) CryoValve, Pulmonary Valve & Conduit. Donor #65989, Model #PV00. Recall # Z-0684-05; c) CryoValve, Aortic Valve & Conduit. Donor #75651, Model #AV00. Recall # Z-0685-05.
REASON: During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the “Last Seen Alive” time in their calculation.
CLASS III
MANUFACTURER: Rusch Inc, Duluth, GA. Firm initiated recall is ongoing. Recalling Firm: Teleflex Medical, Inc., Duluth, GA, by letter on May 13, 2004 and November 22, 2004.
PRODUCT: a) Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt,**1000 ml Lot **Sterile EO. Recall # Z-0647-05; b) Latex-Free REF B1000P Belly Bag Urine Collection Bag with Sample Port **1000 ml Lot **Sterile EO*** Single use only. Recall # Z-0648-05.
REASON: Firm received complaints of leaking urine collection bags.
MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, letters dated February 15, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. Recall # Z-0649-05; b) Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. Recall # Z-0650-05; c) Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. Recall # Z-0651-05.
REASON: The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 6, 2005:
CLASS II
MANUFACTURER: Compumedics USA, Ltd., El Paso, TX, by letter on February 24, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Compumedics E-Series Digital Amplifier System partnumber 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia. Recall # Z-0652-05;b) Nonin Xpod Oximeter model numbers 3011 and 3012,distributed for use with the Compumedics E-Series Digital Amplifier. Recall # Z-0653-05.
REASON: Under specific conditions, the housing of the pulse oximeter connected to the amplifier can become excessively warm causing a burn upon contact with skin.
MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated February 28, 2005. Firm initiated recall is ongoing.
PRODUCT: a) ABSOLOK Extra Absorbable Ligating Clip cartridges,
small, code AP100. Ten cartridges are packaged per box. Recall #
Z-0654-05;b) ABSOLOK Extra Absorbable Ligating Clip cartridges,medium,
code AP200. Ten cartridges are packaged per box. Recall # Z-0655-05;c)
ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code
AP300. Ten cartridges are packaged per box. Recall # Z-0656-05.d) ABSOLOK
Extra Absorbable Ligating Clip cartridges,large, code AP400. Ten
cartridges are packaged per box. Recall # Z-0657-05.
REASON: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
MANUFACTURER: Bio-Rad Laboratories, Inc, Redmond, WA, by letters on January 25-27, 2005 and January 31, 2005. Firm initiated recall is complete.
PRODUCT: Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France. Recall # Z-0659-05.
REASON: New instructions to recommend against using samples with visibly high level of blood.
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 1, 2005. Firm initiated recall is ongoing
PRODUCT: Hill-Rom Total Care SpO2RT pulmonary therapy bed system, Model 1900. Recall # Z-0661-05.
REASON: Siderails may stay up without latching into place.
MANUFACTURER: Nellcor Puritan Bennett, Pleasanton, CA, by letters on October 18, 2004, and December 9, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland. Recall # Z-0662-05;b) Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland; Recall # Z-0663-05;c) Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Recall # Z-0664-05;d) Nellcor brand Pulse Oximeter, model N-395,Made in Ireland; Recall # Z-0665-05.
REASON: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letters dated March 17, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Terumo Advanced Perfusion System 1 (with 6 inch diameter roller pump), Catalog number 801041. Recall # Z-0666-05;b) Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump), Catalog number 801040. Recall # Z-0667-05.
REASON: The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 2, 2005:
CLASS II
MANUFACTURER: Zimmer Spine, Inc., Minneapolis, MN, by letters dated May 25, 2004. Firm initiated recall is ongoing.
PRODUCT: Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets. Recall # Z-1014-04.
REASON: The recalled bone taps could break inside the vertebral body during the tapping process.
MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by Customer Bulletin on June 30, 2004. Firm initiated recall is ongoing.
PRODUCT: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Recall # Z-1118-04.
REASON: Lower than expected results are obtained.
MANUFACTURER: General Electric Med Systems LLC, Waukesha, WI, by Field Service Engineer visit, beginning on October24, 2004. Firm initiated recall is ongoing.
PRODUCT: he device generates whole body and head multislice X-ray computed tomography images that are used by the physician in the diagnosis of disease. Brand Name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Recall # Z-0269-05.
REASON: Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
MANUFACTURER: Toshiba America Medical Systems, Tustin, CA, by Service Representative visit beginning on February 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Model Number KXO-80G X-ray High Voltage Generator for Diagnostic Radiology use. Recall # Z-0494-05.
REASON: The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(a)(1) - Pre-exposure indication of the technique factors to be used during an exposure. Following an AEC exposure, the selected exposure time is indicated, but subsequent exposures are at the preset back-up time.
MANUFACTURER: E-Z-Em Co., Inc., Westbury, NY, by letters dated December 3, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25î), M (21.50î), and L (34.50î), i.e. 9886L. Recall # Z-0548-05; b) Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25"), M (21.50"), and L (34.50"), i.e. 9886L. Recall # Z-0549-05; c) Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25"), M (21.50"), and L (34.50"), i.e. 9886L. Recall # Z-0550-05.
REASON: Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
MANUFACTURER: Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December l7, 2004. Firm initiated recall is ongoing.
PRODUCT: RT130 and RT131 Neonatal/Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. Recall # Z-0553-05.
REASON: Pressure elbow may be partly occluded.
MANUFACTURER: Lemaitre Vascular, Inc., Burlington, MA, by letter on February 7, 2005. Firm initiated recall is ongoing.
PRODUCT: a) LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26. Recall # Z-0557-05; b) LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon Volume 0.2 ml, Length 80 cm. Latex Model: 1601-38. Recall # Z-0558-05; c) LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm. Latex Model: 1601-48. Recall # Z-0559-05; d) LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm. Latex Model: 1601-58. Recall # Z-0560-05; e) LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 80 cm. Latex Model: 1601-28. Recall # Z-0561-05.
REASON: Product sterility maybe compromised due to defective packaging.
MANUFACTURER: TissueLink Medical, Inc., Dover, NH, by letter from February 7, 2005 to February 8, 2005. Firm initiated recall is ongoing.
PRODUCT: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1. Recall # Z-0563-05.
REASON: The tip may separate from the device and render it unusable.
MANUFACTURER: Zimmer Orthopaedic Surgical Products, Statesville, NC, by letter on February 11, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer? Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff. The cuff is a sterile, single use product equipped with an integral fill line and packed 10 cuffs per unit. Cat #60-7080-002-00, Cat #60-7080-003-00, and Cat #60-7080-002-00. Recall # Z-0564-05; b) Zimmer? Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff. The cuff is a sterile, single use product equipped with an integral fill line and packed 10 cuffs per unit. Cat #60-7085-003-00, Cat #60-7085-002-00. Recall # Z-0565-05.
REASON: The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by letter on October 15, 2004. Firm initiated recall is ongoing.
PRODUCT: Deltec Cozmo 3 ml Insulin Cartridge with 0.7 mm (22G) x 12.5mm (1/2 in.) needle and cap. Reorder #21-1750-24. Made in Mexico. Labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged, Rx Only Recall # Z-0566-05.
REASON: Complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber.
CLASS III
MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter in November 2004. Firm initiated recall is ongoing.
PRODUCT: Cypher BX Velocity Cardio Sirolimus Eluting Stents. All CWSXXXXX and CRSXXXXX.BX Velocity stent coated with the pharmaceutical agent, Sirolimus. Recall # Z-0555-05.
REASON: Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on October 27, 2004. Firm initiated recall is ongoing. PRODUCT: The Triathlon Posteriorly Stabilized Femoral Component. Recall Z-0556-05.
REASON: The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 9, 2005:
CLASS I
MANUFACTURER: IV Flush LLC, Rowlett, TX, by letter on January 26, 2005 and February 16, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Heparin Lock Flush Solution. Recall # Z-0545-05; b) Sodium Chloride Injection USP. Recall # Z-0546-05.
REASON: Device marketed without 510(k) clearance and is suspected to be contaminated with P. Fluorescens.
CLASS II
MANUFACTURER: Greer Laboratories, Inc., Lenoir, NC, by telephone and letter on January 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Sterile Empty Vials for Allergenic Extracts, 100ml size. Recall # Z-0567-05.
REASON: Product may not be sterile.
MANUFACTURER: Alaris Medical Systems Inc, San Diego, CA, by letter on November 15, 2004. Firm initiated recall is ongoing.
PRODUCT: Model 8100 Series Medley Medication Safety System Pump Module. Recall # Z-0568-05.
REASON: The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
MANUFACTURER: Ross Products Division Abbott Laboratories, Columbus, OH, by telephone and letter on August 18, 2004. Firm initiated recall is ongoing.
PRODUCT: Flexiflo Quantum Enteral Pump. Recall # Z-0570-05.
REASON: Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
MANUFACTURER: Maquet, Inc, Bridgewater, NJ, by letter on January 3, 2005. Firm initiated recall is ongoing.
PRODUCT: Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. Recall # Z-0571-05.
REASON: Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone on September 10, 2003. Firm initiated recall is ongoing.
PRODUCT: Varcella Zoster ELISA kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. Recall # Z-0572-05.
REASON: Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
MANUFACTURER: Roche Diagnostics Corp, Indianapolis, IN, by letters dated February 15, 2005. Firm initiated recall is ongoing. PRODUCT: a) BioTek brand Automated Microplate Reader; Model Elx800, Roche catalog number 21045059001. Recall # Z-0573-05; b) BioTek brand Automated Microplate Reader; Model Elx808, Roche catalog number 03145387001. Recall # Z-0574-05.
REASON: The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
MANUFACTURER: Deals Nothing Over A Dollar, Earth City, MO, by e-mail on February 16, 2005. Firm initiated recall is ongoing.
PRODUCT: Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged; Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494. The individually packaged toothbrushes are packaged 49 per case labeled as Decent Trading Adult Battery Operated Toothbrush. Recall # Z-0575-05.
REASON: A defective seal allows water into the handle of the toothbrush via the bristles, and rusty water seeps back out of the toothbrush around the bristles.
MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on February 23, 2005. Firm initiated recall is ongoing.
PRODUCT: Access Immunoasay Systems Digoxin Reagent. Recall # Z-0576-05.
REASON: Variability in results on Patient and QC results of 20-25%, high and low.
CLASS III
In the March 2, 2005 (05-09) Enforcement Report, Recall # Z-0555-05 should read as follows:
MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter on November 16, 2004. All Cypher product at U.S. hospitals was inspected between 11/17/2004 and 12/16/2004 for potential incorrect expiration date on Inventory Control Stickers applied at hospitals. None were found. Firm initiated Field Inspection is complete. All product involved in the inspection has expired. (CORRECTION)
PRODUCT: Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System (CXSxxxxx). (CORRECTION) Recall # Z-0555-05.
REASON: Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on October 22, 2004. Firm initiated recall is ongoing.
PRODUCT: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23. Recall # Z-0569-05.
REASON: Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga). Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 16, 2005:
CLASS I
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond,WA, by letter on February 3, 2005 and by telephone and letter beginning on March 1, 2005. Firm initiated recall is ongoing.
PRODUCT: LIFEPAK 500 AED. Recall # Z-0562-05.
REASON: Potential to not detect patients at the low end of the patient impedance range.
CLASS II
MANUFACTURER: Medline Industries, Inc., Waukegan, IL, by letters dated March 4, 2005. Firm initiated recall is ongoing.
PRODUCT: Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick. Recall # Z-0554-05.
REASON: There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.
MANUFACTURER: DeRoyal Technologies, Inc., New Tazewell, TN, by letter on November 22, 2004. Firm initiated recall is ongoing.
PRODUCT: Cold Therapy Blanket. Recall # Z-0577-05.
REASON: There is a possibility of water leaking from the welded seam of the blanket.
MANUFACTURER: Sybaritic, Inc., Bloomington, MN, by telephone on January 5, 2005. Firm initiated recall is ongoing.
PRODUCT: Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System. Recall # Z-0578-05.
REASON: Device is performing functions that are not cleared in the 510(k).
MANUFACTURER: Dentsply Friadent Ceramed, Lakewood, CO, by letters dated February 17, 2005. Firm initiated recall is ongoing.
PRODUCT: PepGen P-15 Putty(0.5cc). Article Number: 99U200-005. Recall # Z-0579-05.
REASON: PepGen P-15 Putty kit was labeled with the incorrect expiration date.
MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by telephone on June 6, 2003. Firm initiated recall is complete.
PRODUCT: KinAir MedSurg, flotation therapy, powered hospital bed. Recall # Z-0583-05.
REASON: Weld failure causes side rail welds to turn upside down or break off of the bed.
MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone on February 3, 2005, and letters dated February 10, 2005. Firm initiated recall is ongoing.
PRODUCT: a) BD Nexiva Closed IV Catheter System, 18 gauge. Catalog Numbers: 383508, 383509. Recall # Z-0584-05; b) BD Nexiva Closed IV Catheter System, 20 gauge. Catalog Numbers: 383505, 383506, 383507. Recall # Z-0585-05; c) BD Nexiva Closed IV Catheter System, 22 gauge. Catalog Number: 383502. Recall # Z-0586-05; d) BD Nexiva Closed IV Catheter System, 24 gauge. Catalog Numbers: 383500, 383501. Recall # Z-0587-05; REASON: The Y-luer connection may crack during normal product use. MANUFACTURER: Proctor & Gamble CO., Cincinnati, OH, by letter dated February 23, 2005 and March 4, 2005. Firm initiated recall is ongoing. PRODUCT: a) The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191. Recall # Z-0589-05; b) The product is a battery operated toothbrush. Spinbrush Pro Whitening Medium battery operated toothbrushes UPC 76687800193. Recall # Z-0590-05; c) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening EX Soft Refill Heads, UPC776687800192.Recall # Z-0591-05; d) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refill Heads, UPC776687800194.Recall # Z-0592-05; e) The product is a Spinbrush Pro EX Soft battery operated toothbrushes. UPC 76687800078. Recall # Z-0593-05; f) The product is a Spinbrush Pro Medium battery operated toothbrushes. UPC 76687800079. Recall # Z-0594-05; g) The product is a Spinbrush Pro EX Soft battery powered Refill heads for battery powered toothbrushes. UPC 776687800080. Recall # Z-0595-05; h) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Medium Refill heads, UPC 776687800081. Recall # Z-0596-05.
REASON: The brushes may experience head breakage when insufficiently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate
MANUFACTURER: Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter starting on February 10, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD) devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user- selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers. Recall # Z-0597-05; b) Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0598-05; c) Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0599-05; d) Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0600-05; e) Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0601-05; f) Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0602-05; g) Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0603-05; h) Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0604-05.
REASON: Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letters dated December 21, 2004 and January 3, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer. Ref/No. 03112276180; Part number BP5016. Recall # Z-0605-05; b) Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer; Ref/No. 03112349180, Part number BP5186. Recall # Z-0606-05; c) Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer; Ref/No. 03112314018, Part number BP5032. Recall # Z-0607-05; d) Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opera system only, Manufacturer part number T01-3606-01, Roche part number 03361322001. Recall # Z-0608-05; e) Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001. Recall # Z-0609-05; f) AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182. Recall # Z-0610-05; g) Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001. Recall # Z-0611-05.
REASON: A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
CLASS III
MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on December 17, 2004. Firm initiated recall is ongoing.
PRODUCT: a) CryoValve, Pulmonary Valve & Conduit. Donor #62654, Model #PV00. Recall # Z-0580-05; b) CryoValve, Aortic Valve and Conduit. Donor #62654, Model #AV00. Recall # Z-0581-05.
REASON: Records noted that the infant donor's mother had tested positive for Hepatitis B.
MANUFACTURER: Teleflex Medical, Bannockburn, IL, by letter dated January 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm). Recall # Z0582-05.
REASON: Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter dated April 30, 2004. Firm initiated recall is complete.
PRODUCT: Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S. Recall # Z-0588-05.
REASON: The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 23, 2005:
CLASS II
MANUFACTURER: Hospira, Inc., Lake Forest, IL, by letter on November 10, 2004 or by telephone on November 11, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. Recall # Z-0617-05; b) Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. Recall # Z-0618-05; c) Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. Recall # Z-0619-05; d) Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. Recall # Z-0620-05; e) Catheterization Kits containing Angiographic Syringes with Rotator Connector. Recall # Z-0621-05
REASON: Syringes could possibly allow air to enter the patient's vascular system.
CLASS III
MANUFACTURER: Medtronic Neurosurgery, Goleta, CA, by letters on February 28, 2005. Firm initiated recall is ongoing.
PRODUCT: a) MurphyScope, Bayonet, Malleable, Catalog # 2121-157. Recall # Z-0615-05; b) MurphyScope, Curved, Malleable, Catalog # 2125-163. Recall # Z-0616-05.
REASON: Products are mislabeled. Each designated lot contains the other model. Bayonet type contains Curved and vice versa.
MANUFACTURER: Integra Neuro Sciences, San Diego, CA, by letter on January 21, 2005. Firm initiated recall is ongoing.
PRODUCT: a) LICOX Complete Brain IMC Probe Kit, Model IM3.ST C. Recall # Z-0622-05; b) LICOX temperature probe, Model C8.B. Recall # Z-0623-05.
REASON LICOX Model C8.B temperature probes may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
MANUFACTURER: Heraeus Kulzer Inc., South Bend, IN, by letter on or about November 1, 2003. Firm initiated recall is complete.
PRODUCT: a) Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360), catalog number 66009585 Dental impression material. Recall # Z-0624-05; b) Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy+Light, catalog number 66009583. Recall # Z-0625-05; c) Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360), catalog number 66009584. Recall # Z-0626-05; d) Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase, catalog number 66009582. Recall # Z-0627-05.
REASON: Packaging defects could result in improper mixing ratios and unusable impressions. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 30, 2005:
CLASS I
MANUFACTURER: Heartsine Technologies, Inc., San Clemente, CA, by telephone and letters on February 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Heartsine Samaritan AED Defibrillators -- Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05.
REASON: The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
CLASS II
MANUFACTURER: Bioteque America Inc., Langhorne, PA, by telephone on February 23, 2005 and by letter dated February 24, 2005. Firm initiated recall is ongoing.
PRODUCT: Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvck pouch. Recall # Z-0027-05.
REASON: Product is marked without a 510(k).
MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letters dated January 10, 2005. Firm initiated recall is complete.
PRODUCT: a) BD Exacta 8.5 Fr Percutaneous Sheath IntroducerTray. Ref. No 680124. Recall # Z-0628-05;b) Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray. Ref. No. 681714. Recall # Z-0629-05;c) Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray. Ref. No. 681725. Recall # Z-0630-05;d) BD Exacta 6Fr Percutaneous Sheath Introducer Tray. Recall # Z-0631-05.
REASON: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
MANUFACTURER: Diasorin Inc., Stillwater, MN, by letter on January 22,2004. Firm initiated recall is ongoing.
PRODUCT: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Recall # Z-0632-05.
REASON: DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
MANUFACTURER: Millar Instruments, Inc., Houston, TX, by e-mail on
January 14, 2005 and letter on January 20, 2005. Firm initiated recall is
ongoing.
PRODUCT: Mikro-Tip Disposable Angiographic Catheter. Recall # Z-0635-05.
REASON: Wire braiding protruding from the catheter.
MANUFACTURER: Boston Scientific, San Jose, CA, by letters on February 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8060, 8075. Recall # Z-0639-05.
REASON: The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
MANUFACTURER: Philips Medical Systems Sales and Service Region No. America, Bothell, WA, by letter on December 21, 2004. Firm initiated recall is ongoing.
PRODUCT: Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05.
REASON: Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
MANUFACTURER: Recalling Firm: Cypress Medical Products, Ltd., McHenry, IL, by telephone on May 3, 2004, and by telephone and letters dated March 3, 2005. Manufacturer: Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA. Firm initiated recall is ongoing.
PRODUCT: a) Manual Mechanical Wheelchair, 18" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrestreorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest. Recall # Z-0642-05;b) Manual Mechanical Wheelchair, 16" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7910: Fixed Full Arm, Swing Footrest reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7912: Removable Desk Arm, Swing Footrest reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7914: RemovableFull Arm, Elevating Adjustable Legrest. Recall # Z-0643-05;c) Manual Mechanical Wheelchair, 24" seat, maximum patient weight: 450 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7920: Removable Desk Arm, Swing Footrest reorder 16-7921: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7922: RemovableFull Arm, Elevating Adjustable Legrest. Recall # Z-0644-05;d) Manual Mechanical Wheelchair, 20" seat, maximum patient weight: 350 lbs., Made in China; the wheelchairs were sold in the following configurations: reorder 16-7942: Removable Desk Arm, Swing Footrest reorder 16-7943: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7944: Removable Full Arm, Elevating Adjustable Legres. Recall # Z-0645-05;e) Manual Mechanical Wheelchair, 22" seat, maximum patient weight: 350 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7952:Removable Desk Arm, Swing Footrest reorder 16-7953: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7954: Removable Full Arm, Elevating Adjustable Legrest. Recall # Z-0646-05.
REASON: The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
CLASS III
MANUFACTURER: DiaSorin Inc., Stillwater, MN, by letters on October 20, 2004. Firm initiated recall is ongoing.
PRODUCT: ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. Recall # Z-0633-05.
REASON: 2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.
MANUFACTURER: DiaSorin, Stillwater, MN, by letter. Firm initiated recall is ongoing.
PRODUCT: DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725. for the quantitative determination of androstenedione levels in serum. Recall # Z-0634-05.
REASON: Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters on January 10, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817,
480 mL bulk catalog # 95046B;
b) 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits
Catalog # 86084, for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ
Test System. Recall # Z-0636-05.
REASON: QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Liaison 25 OH Vitamin D Assay, catalog # 310900. Recall # Z-0637-05.
REASON: Results of an internal inspection show Lot 114439E to have calibrator 1 and calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Liaison 25 OH Vitamin D Assay, Manufacturer part # 310900. Recall # Z-0638-05.
REASON: An internal inspection indicates that calibrator 2 and
conjugate are switched in their positions in the integral. This will
result in calibrator 1 RLU's similar to that of background RLU, and
calibrator 2 RLU's near expected range. A curve can not be calculated from
this data.
Please visit our websites at www.mdiconsultants.com for more information
on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 23, 2005:
CLASS II
MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter on December 3, 2004. Firm initiated recall is ongoing.
PRODUCT: Advanced D-Dimer. Fibrinogen and fibrin split products, Catalog numbers OQWM11 AND OQEM13. Recall # Z-0538-05.
REASON: Decrease in product stability after reconstitution and reduced stability on board certain instrument systems.
MANUFACTURER: Zimmer Austin, Inc., Austin, TX, by letter on December 17, 2004. Firm initiated recall is ongoing.
PRODUCT: Most Options System Porous and Non-Porous Revision Stem Adapters. Catalog Numbers: 5000-50-100 and 5000-50-200. Recall # Z-0539-05.
REASON: Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
MANUFACTURER: Plus Orthopedics, San Diego, CA, by telephone and personal visit, on January 4, 2005. Firm initiated recall is complete.
PRODUCT: UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm. Recall # Z-0540-05.
REASON: Knee tibial insert is mislabeled completely as different device.
MANUFACTURER: Ups Supply Chain Solutions, Alpharetta, GA, by letters dated February 4, 2005. Firm initiated recall is ongoing.
PRODUCT: Rapid Syphilis Test Kit, per insert, contents of the kit are 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging. Recall # Z-0542-05.
REASON: The kits are not approved for use in the United States.
CLASS III
MANUFACTURER: Diagnostic Products, Corp, Los Angeles, CA, by telephone, email or fax on January 24 and 25, 2005. Firm initiated recall is ongoing.
PRODUCT: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB 2, L2KVB6. Recall # Z-0537-05.
REASON: A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
MANUFACTURER: Diamedix Corp., Miami, FL, by letter on December 23, 2004. Firm initiated recall is ongoing.
PRODUCT: Legionella ELISA Test System. The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Recall # Z-0541-05.
REASON: The kits may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.
MANUFACTURER: Biolase Technology, Inc., San Clemente, CA, by firm representative visit, on January 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Waterlase MD, dental laser unit, Model #6200218. Recall # Z-0543-05.
REASON: Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
MANUFACTURER: Bausch & Lomb, Inc., Rochester, NY, by letters dated February 4, 2003. Firm initiated recall is ongoing.
PRODUCT: SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with --3.25 DS, -1.25DC, 170 degree Axis. Recall # Z-0544-05.
REASON: Portion of lot contains lenses with incorrect refractive power.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 16, 2005:
CLASS I
MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by telephone on January 10, 2005. Firm initiated recall is ongoing.
PRODUCT: BD ProbeTec? ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec? ET Urine Processing Pouches, 25 pouches/bag. Recall # Z-0455-05.
REASON: An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
CLASS II
MANUFACTURER: Cardiac Science, Inc., Minnetonka, MN, by telephone on November 12, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Powerheart AED G3 Automated External Defibrillator Model 9300E. Recall # Z-0398-05; b) Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Recall # Z-0399-05.
REASON: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.
MANUFACTURER: S S C O R Inc., Sun Valley, CA, by letter, on January 6, 2005. Firm initiated recall is ongoing.
PRODUCT: a) SSCOR Suction Device Model 2310BV. Recall # Z-0411-05; b) SSCOR Suction Device Model 2310V. Recall # Z-0412-05; c) SSCOR Suction Device Model 2310BV-230. Recall # Z-0413-05; d) SSCOR Suction Device Model 2314. Recall # Z-0414-05; e) SSCOR Suction Device Model 2314B. Recall # Z-0415-05; f) SSCOR Suction Device Model 2315. Recall # Z-0416-05.
REASON: Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in question is caused by regulators that result in inadequate suction.
MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone and e-mail on November 11, 2004, and by letter on November 16, 2004. Firm initiated recall is ongoing.
PRODUCT: Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Recall # Z-0442-05.
REASON: The catheter became disconnected from the port while implanted in the patient.
MANUFACTURER: Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letters on December 16, 2004. Firm initiated recall is ongoing.
PRODUCT: Internal Battery for Puritan Bennett 700 Series Ventilator. Recall # Z-0444-05.
REASON: Wires on battery may loosen causing disconnection.
MANUFACTURER: Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letter on December 17, 2004. Firm initiated recall is ongoing.
PRODUCT: Puritan Bennett Ventilator System. Model 740 and 760 series. Recall # Z-0445-05.
REASON: Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
MANUFACTURER: Warsaw Orthopedic, Inc., Warsaw, IN, by letters dated December 27, 2004 and January 12, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123. Recall # Z-0446-05; b) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125. Recall # Z-0447-05; c) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. Recall # Z-0448-05; d) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140. Recall # Z-0449-05; e) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142. Recall # Z-0450-05; f) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145. Recall # Z-0451-05.
REASON: The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
MANUFACTURER: International Chemical, Inc., Amherst, NY, by telephone in October 2004, and on December 27, 2004, and by letter on January 10, 2005. Firm initiated recall is ongoing.
PRODUCT: a) OTC Pregnancy Test labeled "CHOICE Pregnancy Test Kit" (PA-410A), midstream, no cups or droppers. Label reads: "One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate." Each box contains one home test kit. Recall # Z-0452-05; b) OTC Pregnancy Test Kit labeled "CHOICE Pregnancy Test Kit" (PA-320), cassette type with cup and dropper. Label states: "Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate." Each box contains one home test kit. Recall # Z-0453-05.
REASON: Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by telephone on October 29, 2004 and November 2, 2004, and by letter on November 1, 2004. Firm initiated recall is ongoing.
PRODUCT: Run Way 6F Cardiovascular Guide Catheter. Recall # Z-0454-05.
REASON: The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon.
MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letters dated November 21, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Endopath EZ45 Endoscopic Linear Cutter (EZ45B). Recall # Z-0457-05; b) Endopath EZ45 No Knife Linear Stapler (NK45B). Recall #Z-0458-05; c) Endopath EZ45 Endoscopic Linear Cutter (EZ45G). Recall #Z-0459-05; d) Endopath EZ45 Endoscopic Linear Cutter (ET45B). Recall #Z-0460-05; e) Endopath EZ45 Endoscopic Linear Cutter (ET45G). Recall #Z-0461-05; f) Endopath EZ45 No Knife Linear Stapler (NK45G). Recall #Z-0462-05.
REASON: The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by visit on April 1, 2004. Firm initiated recall is complete.
PRODUCT: Custom Order Value Pack General Anesthesia Kit, Catalog Number: VP1279, Labeled in part: Contents: 1-Adult Disposable Anesthesia Breathing Circuit **1-Breathing Bag Non-Latex**. Recall # Z-0463-05.
REASON: Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.
MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by facsimile letter on December 3, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C390 (Reorder No. 21-0325-01) 121 inch length/307cm, 28ml priming volume, 20 drops/ml, 0 injection sites. Recall # Z-0464-05; b) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C220 (Reorder No. 21-0323-01) 107 inch length/272 cm, 26ml priming volume, 20 drops/ml, 1 standard injection site. Recall # Z-0465-05; c) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 standard injection sites. Model Number I8C1230J (Reorder No. 21-0301-25) for product distributed to Japan. Model Number I8C1230 (Reorder No. (21-0318-25) for product distributed Internationally. Model Number 8C1230 (Reorder No. 21-0305-01) for product distributed within the United States. Recall # Z-0466-05; d) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States. Recall # Z-0467-05; e) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 standard injection sites. Model Number I8C1630 (Reorder No. 21-0319-25) for product distributed Internationally. Model Number 8C1630 (Reorder No. 21-0306-01) for product distributed within the United States. Recall # Z-0468-05; f) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter. Recall # Z-0469-05; g) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2102 (Reorder No. 21-0309-01) 112 inch length/285 cm, 50ml priming volume, 12 drops/ml (at filter), 1 SureSite Prepierced injection site, 150 micron blood filter, 2 non-vented spikes. Recall # Z-0470-05; h) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CJ4303 (Reorder No. 21-0313-01) 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 SureSite Prepierced injection sites. Recall # Z-0471-05; i) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C230 (Reorder No. (21-0345-25) for product distributed Internationally. Model Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States. Recall # Z-0472-05; j) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Checkvalve Set for secondary (piggyback) Administration described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C4220 (Reorder No. 21-0349-25) for product distributed Internationally. Model Number 8C4220 (Reorder No. 21-0328-01) for product distributed within the United States. Recall # Z-0473-05; k) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AC2029 (Reorder No. 21-0330-01) Speciality Administration Low Adsorption Filter Set has 105 inch length/267 cm, 27.5ml priming volume, 20 drops/ml, 0 injection sites, 0.22 micron air-eliminating filter, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Recall # Z-0474-05; l) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1201 (Reorder No. 21-0333-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 2 SureSite Prepierced Injection sites. Recall # Z-0475-05; m) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Recall # Z-0476-05; n) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2204 (Reorder No. 21-0336-01) Speciality Administration Filter Set has 107 inch length/272 cm, 28ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection sites and 0.22 micron air-eliminating filter. Recall # Z-0477-05; o) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC3217 (Reorder No. 21-0338-01) Speciality Administration Checkvalve Filter Set has 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection sites and 0.22 micron air-eliminating filter. Recall # Z-0478-05; p) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC4203 (Reorder No. 21-0339-01) 105 inch length/267 cm, 25.5ml priming volume, 20 drops/ml,2 SureSite Prepierced Injection Sites. Recall # Z-0479-05; q) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CF4203 (Reorder No. 21-0340-01) 105 inch length/267 cm, 25ml priming volume, 60 drops/ml, 2 SureSite Prepierced Injection Sites. Recall # Z-0480-05; r) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection Sites. Recall # Z-0481-05; s) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injection Sites Burette set. Recall # Z-0482-05; t) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NK4303 (Reorder No. 21-0427-01) described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 Luer-Activated Valve injection Sites Burette set. Recall # Z-0483-05; u) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NC1301 (Reorder No. 21-0428-01) Primary Checkvalve for Secondary (piggyback) Administration set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injection Sites. Recall # Z-0484-05; v) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ2304 (Reorder No. 21-0433-01) Burette Administration Set described as 110 inch length/279 cm, 20ml priming volume, 20 drops/ml, 3 Luer-Activated Valve Injection Sites. Recall # Z-0485-05; w) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C4209 (Reorder No. 21-0327-01) Primary one-way Checkvalve below pump Administration set described as 115 inch length/292 cm, 27.5ml priming volume, 20 drops/ml and 3 injection Sites.Recall # Z-0486-05; x) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 injection Site. Recall # Z-0487-05; y) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C825 (Reorder No. 21-0347-25) Specialty Administration set described as 109 inch length/277 cm, 26ml priming volume, 20 drops/ml and 1 injection Site. Recall # Z-0488-05; z) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C4240J (Reorder No. 21-0352-25) Specialty Administration set described as 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml and 2 injection Sites and 0.22 micron filter. Recall # Z-0489-05; aa) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needleless Injection Site. Recall # Z-0490-05; bb) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC42124 (Reorder No. 21-0441-25) Specialty Administration set described as 109 inch length/277 cm, 26ml priming volume, 20 drops/ml and 1 Needleless injection Site, 15 micron filter. Recall # Z-0491-05; cc) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC1201 (Reorder No. 21-0442-25) Primary Checkvalve Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 2 Needleless Injection Sites. Recall # Z-0492-05;
REASON: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leak past and may cause an inaccurate infusion rate.
MANUFACTURER: Ethicon, Inc., Somerville, NJ, by letter on December 14, 2004. Firm initiated recall is ongoing.
PRODUCT: Versapoint, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). The product subject of this recall is the connector cable which goes between the electrosurgical generator and the electrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization. Product code 00480. Recall # Z-0493-05.
REASON: Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on January 15, 2005, and January 17, 2005. Firm initiated recall is ongoing.
PRODUCT: Lifepak 12 defibrillator/monitors biphasic. Recall # Z-0495-05.
REASON: The monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
MANUFACTURER: Stelkast Co., McMurray, PA, by telephone on September 24, 2004. Firm initiated recall is complete.
PRODUCT: Proven Porous CR Femur, Implantable orthopedic device. Recall # Z-0496-05.
REASON: Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch.
MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated December 20, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=112mm, C=82mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-82. Recall # Z-0498-05; b) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=112mm, C=82mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-82. Recall # Z-0499-05; c) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=112mm, C=82mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-82. Recall # Z-0500-05; d) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-82. Recall # Z-0501-05; e) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-82. Recall # Z-0502-05; f) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-82. Recall # Z-0503-05; g) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=126mm, C=96mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-96. Recall # Z-0504-05; h) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=126mm, C=96mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-96. Recall # Z-0505-05; i) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=126mm, C=96mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-96. Recall # Z-0506-05; j) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-96. Recall # Z-0507-05; k) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-96. Recall # Z-0508-05; l) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-96. Recall # Z-0509-05; m) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=141mm, C=111mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-111. Recall # Z-0510-05; n) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=141mm, C=111mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-111. Recall # Z-0511-05; o) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=141mm, C=111mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-111. Recall # Z-0512-05; p) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-111. Recall # Z-0513-05; q) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-111. Recall # Z-0514-05; r) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-111. Recall # Z-0515-05; s) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=155mm, C=125mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-125. Recall # Z-0516-05; t) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=155mm, C=125mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-125. Recall # Z-0517-05; u) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=155mm, C=125mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-125. Recall # Z-0518-05; v) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-125. Recall # Z-0519-05; w) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-125. Recall # Z-0520-05; x) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-125. Recall # Z-0521-05; y) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=170mm, C=140mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-140. Recall # Z-0522-05; z) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-140. Recall # Z-0523-05; aa) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-140. Recall # Z-0524-05; bb) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-140. Recall # Z-0525-05;
REASON: The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
MANUFACTURER: Hu-Friedy Manufacturing Co., Inc., Chicago, IL, by telephone on January 7, 2005 and by letter on January 10, 2005 and January 21, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Product is labeled in part, HENRY SCHEINÆ 101-0913 Explorer #2 D/E. +H658101091306. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0526-05; b) Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-3620 Explorer-Single End #23 SE. +H658100362003. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0527-05; c) Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-8008 Explorer-Double End #5. Bar Code: +H658100800808. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0528-05. d) Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-7409 Explorer -- Single End #7 SE. Bar Code: +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0529-05.
REASON: Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
MANUFACTURER: Interpore Cross International, Inc., Irvine, CA, by letters on January 18, 2005. Firm initiated recall is complete.
PRODUCT: Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers). Recall # Z-0530-05.
REASON: Mislabeled. International Product Information Data Sheet was inadvertently released with the products distributed in the US. International sheet contained an indication for use statement which was not cleared in the USA. This indication is, "nexus, A Geo Structure is indicated for use in an open approach using bone graft materials in patients with degenerative disc disease (DDD) (C2-S1) whose condition required the use of interbody fusion. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s)."
CLASS III
MANUFACTURER: Weck, Research Triangle Park, NC, by letter on October 31, 2001. Firm initiated recall is complete.
PRODUCT: Weck, Endo5, Hem-o-lok? ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems?. Catalog #544965. Recall # Z-0393-05.
REASON: The flush port on some appliers was occluded with an epoxy resin during manufacturing.
MANUFACTURER: Advanced Bionics Corporation, Sylmar, CA, by letter on November 11, 2004. Firm initiated recall is ongoing.
PRODUCT: Charger Assembly, Model # SC-5300, of the Precision Spinal Cord Stimulation System. Recall # Z-0396-05.
REASON: A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by letter on November 30, 2004. Firm initiated recall is ongoing.
PRODUCT: Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately. Recall # Z-0417-05.
REASON: A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.
MANUFACTURER: Weck, Research Triangle Park, NC, by letter on/about May 21, 2003. Firm initiated recall is complete.
PRODUCT: Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6" -- 11 French, Rx Only, Sterile. Catalogue #809600. Recall # Z-0418-05.
REASON: Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by telephone on September 23, 2004. Firm initiated recall is ongoing.
PRODUCT: Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two -- 6 oz. bottles of TruRepair Powder. Catalog 092160. Recall # Z-0419-05.
REASON: The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If the Trusoft liquid is used the repair material will not set up.
MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.
PRODUCT: Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray. 12 trays per bag; catalog 0921885. UPC +D68109218850G. Recall # Z-0420-05.
REASON: The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by telephone on September 2, 2004 and by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.
PRODUCT: Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator -- Blue, and one 7.5 oz, tube of Base -- White, which are mixed as needed to make the registration paste. Catalog 0921815. Recall # Z-0421-05.
REASON: The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated December 10, 2004. Firm initiated recall is ongoing.
PRODUCT: Mammotome EX Holster. Recall # Z-0440-05.
REASON: A capacitor of the wrong value was used. With the improper capacitor, the speed is reduced. This may lead to failure to completely close. If it does occur, the result may be a decrease in sample size, some tearing of the tissue or no specimen at all (dry tap).
MANUFACTURER: Power Surgical Solutions, Fort Worth, TX, by letter on January 3, 2005. Firm initiated recall is ongoing.
PRODUCT: Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D. Recall # Z-441-05.
REASON: Device is missing the sub-collet component within the dissecting tool package.
MANUFACTURER: Baxter Healthcare, Corp., Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.
PRODUCT: Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar; 60 sets per case. Recall # Z-0443-05.
REASON: The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
MANUFACTURER: BioMerieux, Durham, NC, by letter on September 17, 2004. Firm initiated recall is ongoing.
PRODUCT: BacT/Alert? (BTA) Classic instruments. Recall # Z-0456-05.
REASON: Over heating of memory board.
MANUFACTURER: Smiths Medical ASD, Inc., Rockland, MA, by letter on December 15, 2004. Firm initiated recall is ongoing.
PRODUCT: Equator Forced Air Convective Warming System, Reference Number EQ 5000. Recall # Z-0497-05.
REASON: Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 9, 2005:
CLASS I
MANUFACTURER: Bio-Med Devices, Inc., Guilford, CT, by fax on December 7, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: ":PATIENT BREATHING CIRCUIT =-=-= CONTENTS: 1-PATIENT HOSE 2mmIDx42" 1-PRESSURE GAGE LINE 3/16"IDx54" 1-PATIENT HOSE 22mmIDx24" 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6" 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM & 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1û4"ID x 5/4" 1-EXHALATION VALVE LINE 1/8"IDx52" Recall # Z-0423-05; b) Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72" w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8"IDx84" 1-TEE 1/8"x1/8"x1/8" 1-LINE 1/8"IDx24" 1-HOLDING ARM 1-LINE 1/8"IDx2" 1-CUFF 1û4"IDx2". Recall # Z-0424-05; c) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENTBREATHING CIRCUIT =-=- CONTENTS: 1-PATIENT HOSE 22mmIDx42" 1-PRESSURE GAGE LINE 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 48" w/CUFF 1û4"ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8"IDx48" 2-ADAPTERS 22mmx22mm. Recall # Z-0425-05; d) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx90" 1-PATIENT HOSE 22mmIDx18" 1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE 84" w/CUFF 1û4"ID 1-EXHALATION VALVE w/HOLDING ARM & COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm. Recall # Z-0426-05; e) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT == CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx108" 1-PATIENT HOSE 22mmIDx36" 1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM & COLLECTION HEAD 102" w/CUFF 1û4"ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm. Recall # Z-0427-05; f) Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60"2- TUBING FITTINGS 1- 22x22mm ADAPTER. Recall # Z-0428-05; g) Bio-Med Patient Breathing Circuit Product Number: 3030-5 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =- CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-PRESSURE GAGE LINE 1/8"IDx72" 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8"IDx72 2-ADAPTERS 22mmx22mm. Recall # Z-0429-05; h) Bio-Med Dental Breathing Circuit Product Number: DENTL. Recall # Z-0430-05.
REASON: Adapters may be occluded potentially preventing inhalation.
CLASS II
MANUFACTURER: Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by telephone on November 19, 2004. Firm initiated recall is ongoing. - 3 -
PRODUCT: Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained within Medtronic Lot N0016487 bear the primary manufacturer's label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer's labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly ("Lioresal Refill Kit") will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK. Recall # Z-0391-05.
REASON: Outer package of Lioresal Intrethecal Refill Kit, Model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).
MANUFACTURER: Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 8, 2004. Firm initiated recall is ongoing.
PRODUCT: Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05.
REASON: A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same identifier in Logix and another order entry program being used with the Logix software.
MANUFACTURER: Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.
PRODUCT: Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05.
REASON: Logix-CM software version 3.0.4 has not completed its official release process.
MANUFACTURER: Baxter Healthcare, Renal Division, Mc Gaw Park, IL, by letters on May 28, 2003. Firm initiated recall is ongoing.
PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, Altra Touch 1000, Baxter Tina and Baxter Aurora. Recall # Z-0395-05.
REASON: The air detector may not detect air bubbles consistently at the selected limit.
MANUFACTURER: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.
PRODUCT: HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05.
REASON: A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products
MANUFACTURER: Spacelabs Medical Inc., Issaquah, WA, by letter on January 7, 2005 and January 14, 2005. Firm initiated recall is ongoing.
PRODUCT: Ultraview Universal Clinical Workstation System, Model 90385. Recall # Z-0422-05.
REASON: Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
MANUFACTURER: Harvard Clinical Technology, Natick, MA, by letter and telephone on November 3, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001. Recall # Z-0431-05; b) Harvard 1 Single Channel Syringe Infusion Pump P/N 2003-001. Recall # Z-0432-05.
REASON: Potential pump motor/encoder assembly failure may cause over infusing medication in patients.
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on December 14 and 16, 2004. Firm initiated recall is ongoing
PRODUCT: B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers. List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.
REASON: Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover B-12 results are not impacted.
MANUFACTURER: Medivance, Inc., Louisville, CO, by telephone and letter on January 5/6, 2005. Firm initiated recall is ongoing.
PRODUCT: Arctic Sun Temperature Management System, Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.
REASON: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on January 12, 2005. Firm initiated recall is ongoing.
PRODUCT: Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. Recall # Z-0437-05.
REASON: Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specifications were met.
MANUFACTURER: Hospira, Inc., Morgan Hill, CA, by letter on September 8, 2004. Firm initiated recall is ongoing.
PRODUCT: a) The Hospira Plum A + I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Recall # Z-0438-05; b) The Hospira Plum A + 3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Recall # Z-0439-05.
REASON: The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 2, 2005:
CLASS II
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by telephone on December 16, 2004, and advisory notice on December 27, 2004. Firm initiated recall is complete.
PRODUCT: Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080. Recal # Z-0401-05.
REASON: The label on the outside of the shipping box has an incorrect description of the screw diameter.
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated December 29, 2004. Firm initiated recall is ongoing.
PRODUCT: Hill-Rom brand VersaCare Bed; product P3200. Recall # Z-0402-05.
REASON: A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame
MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letters dated November 22, 2004. Firm initiated recall is ongoing.
PRODUCT: a) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0403-05; b) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap. Recall # Z-0404-05; c) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Each KIT contains: Catheter; caps; tape measure, 60 cm length;stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 1.5 inch introducer needle with echogenic tip; 30 cm floppy tip guidewire; 5cm peelable introducer sheath with locking dilator; 10 ml syringe; scalpel, CSR wrap. Recall # Z-0405-05; d) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart. Recall # Z-0406-05; e) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT ‚ Catalog #60M120521, UPN # M00160M1205210; DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0407-05; f) PASV PICC CUSTOM KIT, 3F, single lumen ‚ Catalog # 60M195071, UPN # M00160M1950710. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0408-05; g) VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - Catalog # 60M210624, UPN #M00160M2106240. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0409-05; h) PASV PICC, 3F, single lumen, CUSTOM KIT. Catalog #60M220991, UPN #M00160M2209910. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0410-05.
REASON: Catheter separation immediately distal to the nose of the suture wing.
MANUFACTURER: Harvard Clinical Technology, Natick, MA, by letter on November 3, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Harvard 2 Dual Channel Syringe Infusion Pump P/N 20001-001. Recall # Z-0431-05; b) Harvard 1 Single Channel Syringe Infusion Pump P/N 2003-001. Recall # Z-0432-05; c) Harvard 2 Syringe Pump, Model Number 2005-001. Recall # Z-0433-05.
REASON: Potential pump motor/encoder assembly failure may cause over infusing medication in patients.
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on December 14, and 16, 2004. Firm initiated recall is ongoing.
PRODUCT: B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.
REASON: Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.
MANUFACTURER: Medivance Inc., Louisville, CO, by telephone and letter on January 5‚6, 2005. Firm initiated recall is ongoing.
PRODUCT: Arctic Sun Temperature Management System. Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.
REASON: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
CLASS III
MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter on December 7, 2004. Firm initiated recall is ongoing.
PRODUCT: VISTA Brite Tip RDC(1) Guiding Catheter. Product Code 67021055, Percutaneous Catheter. Recall # Z-0434-05.
REASON: The product was manufactured such that the distal end had an "RDC" shape rather than the "RDC(1)" shape. The RDC shape has a larger curve.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 19, 2005:
CLASS I
MANUFACTURER: Arrow International, Inc., Reading, PA, by letters dated November 23, 2004 and December 7, 2004 and by press release on December 3, 2004. Firm initiated recall is ongoing.
PRODUCT: NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. Product is shipped in cases of 5 units. Catalog numbers S1PIC1-9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C. Recall # Z-0349-05.
REASON: Complaints of vessel erosion when using this product.
CLASS II
*****CORRECTION*****
Recall # Z-0263-05, from Enforcement Report dated December 15, 2004,
Product was described as "Immulite 2500 Automated Immunoassay Analyzer,
Human chorionic gonadotropin (HCG) test system." The correct product
description is "Immulite 2500 Automated Immunoassay Analyzer, Homocysteine
(HCY) test system."
From Enforcement Report dated December 22, 2004,
PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System,
Model SYS1000; all series 1000 instruments labeled as System 1000.
AltraTouch 1000, Baxter Tina and Baxter Aurora; Recall # Z-0274-05. The
correct Recall number is Z-0395-05.
MANUFACTURER: Proctor & Gamble Co, Cincinnati, OH, by letter on November 11, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Spinbrush Pro Whitening Ex Soft battery operated toothbrush, UPC 7 66878 00191 3. Recall # Z-0375-05; b) Spinbrush Pro Whitening Medium battery operated toothbrush, UPC 7 66878 00193 7. Recall # Z-0376-05; c) Spinbrush Pro Whitening Ex Soft refill heads for battery powered toothbrushs, UPC 7 66878 00192 0. Recall # Z-0377-05; d) Spinbrush Pro Whitening Medium refill heads for battery powered toothbrushs, UPC 7 66878 00194 4. Recall # Z-0378-05
REASON: Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
MANUFACTURER: Fischer Imaging Corp., Denver, Co, by letter on July 9, 2004. Firm initiated recall is ongoing.
PRODUCT: Mammo Test Breast Biopsy System. Recall # Z-0379-05.
REASON: X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning
MANUFACTURER: Pride Mobility Product Corp., Exeter, PA, by a safety alert notification dated July, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Victory Motorized Vehicle, 3 wheel. Recall # Z-0380-05;
b) Victory Motorized Vehicle, 4 wheels. Recall # Z-0381-05.
REASON: Intermittent operation.
MANUFACTURER: Omron Healthcare, Inc., Bannockburn, IL, by Removal Notices dated November 2, 2004. Firm initiated recall is ongoing.
PRODUCT: Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC. Recall # Z-0382-05.
REASON: A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by telephone, letter and fax beginning on December 3, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.
PRODUCT: Roche brand Cardiac Reader. Recall # Z-0383-05.
REASON: Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
MANUFACTURER: Baxter Healthcare Corp, Round Lake, IL, by letters dated November 19, 2004. Firm initiated recall is ongoing.
PRODUCT: Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; A) the following sets were made in Costa Rica: a) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9856 and 2M9856K; b) Baxter Solution Set, 109” (2.8 m), Volume 4.8 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9857; c) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9858 and 2M9858K; d) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9859; e) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9860; f) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9861; g) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9862; h) Baxter Solution Set, 111” (2.9 m), Volume 7.4 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapters, product code 2M9874K; i) Baxter Solution Set, 75” (1.9 m), Volume 3.1 mL, Cassette with AutoClamp Device, Male Luer Lock Adapters, product code 2M9875K; j) Baxter Epidural Set, 115” (2.9 m), Volume 5.0 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9003; k) Baxter Epidural Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2L9004; l) Baxter Epidural Set, 92” (2.3 m), Volume 6.7 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapters, product code 2L9005; m) Baxter Solution Set with Spike, 88” (2.2 m), Volume 4.1 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9006. Recall # Z-0385-05.B) Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; the following sets were made in Mexico: a) Sabraset 56050 – 100 Administration Set with 100 mL Bag and Cassette, 56”, Volume 3 mL, 100 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter; b) Sabraset 56050 – 250 Administration Set with 2500 mL Bag and Cassette, 53”, Volume 3 mL, 250 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter. Recall # Z-0386-05.
REASON: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
MANUFACTURER: Zimmer Orthopaedic Surgical Products, Statesville, NC, by letters on October 27, 2004 and November 11, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer- Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7075-007-00. Recall # Z-0388-05;b) Zimmer- Orthopaedic Surgical Products, Disposable Cuff, 12” (30cm), Single Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7075-002-00. Recall # Z-0389-05;c) Zimmer- Orthopaedic Surgical Products, Disposable Cuff, 12” (30cm), Dual Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7070-002-00. Recall # Z-0390-05.
REASON: The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
CLASS III
MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated November 22, 2004. Firm initiated recall is ongoing.
PRODUCT: Vitros CRP (C-Reactive Protein) Slides. Catalog # 1926740 contains 250 slides, Catalog #809 7990 contains 90 slides. Recall # Z-0387-05.
REASON: Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 12, 2005:
CLASS II
MANUFACTURER: GE Healthcare Technologies, Waukesha, WI, by field service representative beginning on December 27, 2004. Corrections should be completed by May 2005. Firm initiated recall is ongoing.
PRODUCT: Proteus XR/a Radiographic X-ray System; Precision 500D Radiographic/Fluoroscopic X-ray System Use: Diagnostic Radiology. Recall # Z-0219/0220-05.
REASON: The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(g) ‚ Positive Beam Limitation (PBL).
MANUFACTURER: Edwards Lifesciences Research Medical Inc, Midvale, UT, by letter on November 22, 204. Firm initiated recall is ongoing.
PRODUCT: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11". Model EX24D. Recall # Z-0306-05.
REASON: Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
MANUFACTURER: Precision Medical, Inc. Northampton, PA, by letters on November 15, 2004. Firm initiated recall is ongoing
PRODUCT: a) Easy Go Vac Aspirator, Model PM65. Portable suction unit.
Recall # Z-0307-05;
b) Easy Go Vac Aspirator, Model PM65HG. Portable suction unit. Recall #
Z-0308-05.
REASON: Battery charger can be overcharged and overheat.
MANUFACTURER: Ormco Corporation, Glendora, CA, by letters from November 18 thru November 23, 2004. Firm initiated recall is ongoing.
PRODUCT: Titanium Orthos Bracket. Recall # Z-0309-05.
REASON: Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, Fl, by letter on October 29, 2004. Firm initiated recall is ongoing.
PRODUCT: Brand name: NIMô EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIMô EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308. All products are packaged one unit per box. Recall # Z-0310-05.
REASON: The firm received six reports of tubes with wires "out of channel" two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
MANUFACTURER: Medical Industries America Inc, Adel, IA, by telephone on September 3, 2004 and on September 10, 2004. Firm initiated recall is ongoing.
PRODUCT: RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. Recall # Z-0326-05.
REASON: Units could show an error code and stop functioning.
MANUFACTURER: Abbott Laboratories, Columbus, OH, by letter, dated November 12, 2004. Firm initiated recall is ongoing.
PRODUCT: a) 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit
with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use
Sterile Gastrostomy Kits. Recall # Z-0327-05;b) 18 French Ross Flexiflo
Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener Set (List
#51174) Assorted Single Use Sterile Jejunostomy Kits. Recall # Z-0328-05.
c) 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with
T-Fasteners (15cm) for Endoscopic Removal (list #00227). Recall #
Z-0329-05; d) 18 French Ross Flexiflo Over the Guidewire Gastrostomy Basic
Kit with T-Fasteners for Endoscopic Removal (list # 00228). Recall #
Z-0330-05; e) 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit
with T-Fasteners for Endoscopic Removal (list # 00238). Recall #
Z-0331-05;
f) 18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller
T-Fastener Set (list # 50190).
Recall # Z-0332-05; g) 22 French Ross Versa-PEG Complete Gastrostomy Kit,
an Over-the-Wire PEG Method Featuring Tube Removal without Endoscopy (list
# 50520). Recall # Z-0333-05; 20 French Ross Over-the-Guidewire Basic h)
Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal
(Basic) (list # 50728). Recall # Z-0334-05; i) 20 French Ross Flexiflo
Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed Bumper
for Endoscopic Removal (list #50738). Recall # Z-0335-05; j) 20 French
Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip
Bumper (list # 51490). Recall # Z-0336-05; k) 20 French Flexiflo Inverta-PEG
Pull Technique Basic Gastrostomy KIt with Roll-Tip Bumper (list # 52000).
Recall # Z-0337-05; l) 10 French Ross Flexiflo Lap J Laparoscopic
Jejunostomy Kit with Brown/Mueller T-Fastner Set (list #51442). Recall #
Z-0338-05.
REASON: Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed
MANUFACTURER: Beckman Coulter Inc, Brea, CA, by letter on December 3, 2004. Firm initiated recall is ongoing.
PRODUCT: ACT diff 2 Analyzer (Automated differential cell counter). Recall # Z-0339-05.
REASON: Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
MANUFACTURER: Weck, Research Triangle Park, NC, by letter on January 25, 2001. Firm initiated recall is complete.
PRODUCT: Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length
12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systemsô,
Catalog # 394236.
Recall # Z-0340-05.
REASON: An incorrect electrosurgical cord was included in some of the packages.
MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on December 13, 2004. Firm initiated recall is ongoing.
PRODUCT: Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05.
REASON: In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy.
MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 4, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05;b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05;c) Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Made in Singapore; color display screen. Recall # Z-0344-05; d) Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Made in Singapore; color display screen. Recall # Z-0345-05.
REASON: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 29, 2004. Firm initiated recall is ongoing
PRODUCT: Hill-Rom CareAssist Bed; model P1170. Recall # Z-034605.
REASON: Warning label containing instructions for proper electrical grounding was not attached
MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone on November 2, 2004. Firm initiated recall is ongoing.
PRODUCT: Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Recall # Z-0347-05.
REASON: Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. A Cemented Trapezoid Tibial Tray labeled as 4F/4T appeared to dimensionally be a 3F/3T.
MANUFACTURER: Ocular Sciences, Inc. Albuquerque, NM, by courier on December 9, 2004. Firm initiated recall is ongoing.
PRODUCT: Sunsoft Multiples Toric, methafilcon A, clear contact lens. Recall # Z-0348-05.
REASON: Vials containing the lenses are possibly contaminated with residual hydrogen peroxide
MANUFACTURER: AGA Medical Corporation, Golden Valley, MN, by letter November 22- 24, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0350-05;b) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0351-05;c) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0352-05;d) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0353-05;e) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of Delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0354-05;f) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall #Z-0355-05; g) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0356-05; h) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0357-05; i) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0358-05;j) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0359-05; k) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0360-05; l) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0361-05; m) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0362-05; n) AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0363-05; o) AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0364-05; p) AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0365-05;q) AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0366-05.
REASON: Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. Residue was determined to be EAP (Ethoxylated alkyl Phenol).
MANUFACTURER: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letter dated December 14, 2004. Firm initiated recall is ongoing
PRODUCT: System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Recall # Z-0367-05.
REASON: Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism
MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter starting on December 1, 2004. Firm initiated recall is ongoing.
PRODUCT: a) Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811. Recall # Z-0369-05;b) Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812. Recall # Z-0370-05.
REASON: X-Ray system may fall downward and could possibly hit the patient.
MANUFACTURER: Beckman Coulter Inc, Brea, CA, via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004, and by letter dated November 2, 2004. Firm initiated recall is ongoing.
PRODUCT: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Part Number: 386167. Recall # Z-0371-05.
REASON: Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.
MANUFACTURER: Roche Diagnostics Corp. Indianapolis, IN, a letter dated 11/19/04 Firm initiated recall is ongoing.
PRODUCT: ACCU-CHEK Inform meter; catalog No. 3035123.
Recall Z-0372-05.
REASON: A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
MANUFACTURER: Dade Behring, Inc., Newark, DE, by letters dated November 12, 2004. Firm initiated recall is ongoing.
PRODUCT: StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05.
REASON: Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
CLASS III
MANUFACTURER: BD Diagnostic Systems, Grayson, GA, by letter beginning October 20, 2004. Firm initiated recall is ongoing.
PRODUCT: a) BD, Brucella melitensis Antigen. Recall # Z-0311-05;b) BD, Salmonella O Group D Antigen (9-12) (Typhoid O).Recall # Z-0312-05;c) BD, Salmonella Somatic Polyvalent Antiserum (A,B,D). Recall # Z-0313-05;d) BD, Brucella abortus Antigen. Recall # Z-0314-05;e) BD, Salmonella Flagellar d Antigen (Typhoid H). Recall # Z-0315-05;f) BD, Salmonella O Group A Antigen (1-2-12). Recall # Z-0316-05;g) BD, Salmonella O Group B Antigen (1-4-5-12). Recall # Z-0317-05;h) BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d). Recall # Z-0318-05;i) BD, Proteus OX19 Antigen. Recall # Z-0319-05;j) BD, Francisella tularensis Antigen. Recall # Z-0320-05;k) BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19).Recall # Z-0321-05;l) BD, Brucella Postive Control Antiserum (AMS). Recall # Z-0322-05;m) BD, Febrile Antigen Negative Control. Recall # Z-0323-05.
REASON: Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. The Antigen Dilution instructions incorrectly state to dilute "one part antigen in fifty parts 0.85% saline (1:50)". The correct instructions should read "one part antigen in forty-nine parts 0.85% saline (1:50)".
MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA, by telephone on November 19, 2004. Firm initiated recall is ongoing.
PRODUCT: Immulite 2500 insulin Kit. Recall # Z-0324-05.
REASON: Low bias of 10 to 40% at different levels of insulin in samples.
MANUFACTURER: Diamedix Corporation, Miami, FL, by letter dated October 8, 2003. Firm initiated recall is ongoing.
PRODUCT: The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade. The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase. Recall # Z-0325-05.
REASON: Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
MANUFACTURER: Cypress Medical Products, Ltd., McHenry, IL, by telephone and letter on December 1, and December 2, 2004. Firm initiated recall is ongoing.
PRODUCT: McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2" wide; 16-1033-3-STR, 3" wide; 16-1033-4-STR, 4" wide; and 16-1033-6-STR, 6" wide. Recall # Z-0368-05.
REASON: The elastic bandages which are labeled sterile have a lack of assurance of sterility.
