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FDA Recalls

November 3, 1999 - December 29, 1999

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 29, 1999:

CLASS II

MANUFACTURER: Laerdal Medical AS, Stavanger, Norway.

PRODUCT: ELASTIC HEAD STRAP, sold as a standard accessory in the Laerdal Pocket Mask with Oxygen inlet and headstrap, used to facilitate exhaled air ventilation in emergencies, whereby the rescuer exhales air through the mask and into the lungs of the patient. Recall #Z-264-0.

REASON: The headstrap of the device contains latex, which is not declared on the label.

MANUFACTURER: Origin Medsystems, Inc., Menlo Park, California.

PRODUCT: Ancure Endograft System, an endovascular Catheter designed to deliver the Endograft and is completely removed from the patient once Endograft is implanted. A) The Ancure Tube System, indicated for the endovascular treatment of infrarenal abdominal aortic aneurysys; b) The Ancure Bifurcated System, indicated for the endovascular treatment of infrarenal abdominal aortic or aortic-iliac aneurysms. Recall #Z-265/266-0.

REASON: The monofilament tie, used in the manufacturing process, is not removed from the endograft prior to completion of the manufacturing process the attachment system cannot deploy, leaving the implant in a partial deployed state.

MANUFACTURER: Abbott Laboratories, Inc., Irving, Texas.

PRODUCT: Abbott Alcyon Analyzers with Alcyon System Software Version 1.6. Recall #Z-267-0.

REASON: The device may give incorrect tests results or reference ranges when printing the "Complete Report (header)", "Incomplete Report (DRAFT)", and the "Control Results printout."

MANUFACTURER: Nellcor Puritan Bennett, Inc., a division of Mallinckrodt, Inc., Carlsbad, California.

PRODUCT: Nellcor Puritan Bennett ventilator, all model #7200 series types, prescription microprocessor mechanical ventilator which combines microprocessor technology with a Pneumatic system to achieve gas delivery and patient monitoring: several series numbers in domestic and international languages. Recall #Z-276/278-0.

REASON: The ventilators may deliver an unexpected high inspiratory pressure and flow when the following set of parameters are selected at one time: Mode - SIMV, Rate 15, Tidal volume 0.3L, Peak flow 10 liters/min., Flow pattern = sine wave, Peep =5, and Fi02 = 0.6.

MANUFACTURER: LifeLink Tissue Bank, Tampa, Florida.

PRODUCT: Various types of human tissue and bone allografts, contained in either plastic bags or bottle with screw on caps with a computer generated label: a) Dura Mater; b) Dura Strips.

REASON: The firm did not adequately evaluate the combination of blood and colloids used in viral market testing and based the hemodilution determination on the donor's serum total protein.

MANUFACTURER: Bio-Laser Response Corporation, Dr. Alvin Stjernholm, Lakewood, Colorado.

PRODUCT: Bio-Laser Systems, used for biostimulation: a) Model 1000; b) Model 2000; c) Model TUCO. Recall #Z-281/283-0

REASON: The devices failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliances.

CLASS III

MANUFACTURER: China Hewlett-Packard Company, Ltd., Qingdao (cables).

PRODUCT: Patient Cables used in Models: HP M1770A, M1771A, M1772A PageWriter Electrocardiographs and Model 2488A StressWriter testing system. Recall # Z-268/271-0

REASON: Damaged cables may lead to distorted ECG waveforms.

MANUFACTURER: Fujirebio Diagnostics, Inc., Malvern, Pennsylvania.

PRODUCT: PSA Reagent Pack, for the in vitro quantitative measurement of PSA (Prostate Specific Antigen) in serum and plasma. This test is used to monitor response to treatment in patients with prostate cancer and to aid in the identification of recurrence of prostate cancer prior to manifestation of clinical symptoms. The PSA Reagent pack is intended for use with the Vitros Eci Immunodiagnostic System. Recall #Z-272-0.

REASON: Microbial contamination of reagent.

MANUFACTURER: Abbott Laboratories, Inc., Abbott Park, Illinois.

PRODUCT: ARCHITECT Free T3 Reagent Kit; a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triodothyronine (Free T3) in human serum and plasma: a) List6C48-25 - 1 x 100 tests; b) List 6C48-30 - 4 x 500 tests. Recall #Z-273/274-0

REASON: Single analyte high control goes out of specification low, falling below the concentration range listed in the package insert.

MANUFACTURER: Greer Laboratories, Inc., Lenoir, North Carolina.

PRODUCT: Greer Dia-Kit, a diagnostic aid for hypersensitivity pneumonitis. A gel diffusion kit for demonstrating precipitating antibodies.

REASON: When freeze dried product was reconstituted, the bulk manufacturing date was not added to the manufacturing record. This product was given an incorrect expiration date.

MANUFACTURER: Vasamedics, L.L.C., Little Canada, Minnesota.

PRODUCT: Laserflo BPM2 Blood Perfusion Monitor, intended to monitor blood flow and perfusion. Recall #Z-279-0.

REASON: The devices contain a chip at main circuit board position U47 that does not meet performance specifications due to a chip substitution error made by a vendor.

MANUFACTURER: R&D Systems, Inc., Minneapolis, Minnesota.

PRODUCT: Erythropoietin Quantikine IVD Human EPO Immunoassay (ELISA Kit), Catalog number DEP00, used for the in vitro diagnostic determination of erythropoietin concentration in human serum as an aid in the diagnosis of anemia and polycythemia. Recall #Z-280-0.

REASON: Deterioration of kit components leads to incorrect Erythropietin assays.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 22, 1999.

CLASS II

MANUFACTURER: Alaris Medical Systems, San Diego, California.

PRODUCT: IMED Gemini PC-4 Volumetric Infusion Pump and Controller with Version 1.85 Software: a) PC-4 Infusion Pump, Model 1340, 110 volts b) PC-4 Infusion Pump, Model 1341, 220 volts Recall #Z-174/175-0.

REASON: Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages.

MANUFACTURER: i-STAT Canada Limited, Kanata, Ontario, Canada.

PRODUCT: i-STAT Cartridges, manufactured for use with the i-STAT portable analyzer, an in-vitro quantification of arterial, venous or capillary whole blood: a) G3+ Cartridge, Catalog No. 220100 b) EG6+ Cartridge, Catalog No. 220200 c) EG7 + Cartridge, Catalog No. 220300 Recall #Z-216/218-0.

REASON: Devices have the potential to provide incorrect reading and fail to function as intended.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valves: a) Model PVOO b) AVOO Recall #Z-246/247-0.

REASON: Donors did not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Zimmer, Inc., a Bristol-Myers Squibb Company, Warsaw, Indiana.

PRODUCT: Colclough (Love-Kerri) Laminectomy Rongeur, a manual instrument used to remove small pieces of bone. Recall #Z-251-0.

REASON: The 3mm Ronguer was incorrectly identified (etched) and labeled as a 5mm Rongeur.

MANUFACTURER: Guidant Corporation, Cardiac Rhythm Management, St. Paul, Minnesota.

PRODUCT: VENTAK MINI III AICD Automatic Implantable Cardioverter Defibrillators, Models 1772, 1773, 1776, 1782, 1783, 1786, 1788, and 1789. Recall #Z-253/260-0.

REASON: Subpectoral implantation of this device exerts unique forces on its exterior that can be transferred to its interior components and has the potential to affect the device performance.

CLASS III

MANUFACTURER: Stryker Endoscopy, Santa Clara, California.

PRODUCT: Stryker Endoscopy Pressure Sensing Cannula, intended to be used by surgeons on orthopedic joints, including the knee, shoulder, ankle, elbow, wrist for carpal tunnel procedure, and for temporomandibular joints. It is used to sense pressure and also provides fluid to joints. Recall #Z-243-0.

REASON: Product has the potential to separate from the tip end during surgery.

MANUFACTURER: Zimmer Patient Care, Dover, Ohio.

PRODUCT: Miller Bone Cement Injector Flexible Nozzle, 12 inch length, 0.25 O.D., intended for use to fill the intramedullary canal with bone cement and is labeled as sterile. Recall #Z-252-0.

REASON: The packages contained 16 inch nozzles instead of 12 inch, as labeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 15, 1999:

CLASS II

MANUFACTURER: Cryomedical Sciences, Inc., Rockville, Maryland.

PRODUCT: CMS ACCUPROBE 530, a cryosurgical system used for controlled ablation and destruction of malignant/benign tissue in the body. Device supercools liquid nitrogen applied to tissue for destruction. Recall #Z-215-0.

REASON: Device wiring found to be corroded.

MANUFACTURER: Zeus Scientific, Inc., Branchburg, New Jersey.

PRODUCT: Toxo IgM Enzyme-Linked Immunosorbent Assay (ELISA) a) Product No. 1029-315Z, a) Product No. 1029-315Z, Toxo IgM ELISA - 96 Tests; b) Product No. B1029-315Z, Toxo IgM ELISA. Recall #Z-219/220-0.

REASON: Device may produce high rates of false positive test results.

MANUFACTURER: Allegiance Healthcare Corporation, Montgomery, New York

PRODUCT: Procedure Based Delivery Systems Module, used in surgery, composed of subassembly kits, including the set up subassembly kit, which contains a skin/scrub prep tray that had latex gloves packaged in the tray; Packaged by Allegiance Healthcare Corporation. Recall #Z-221/224-0.

REASON: Kits labeled as latex free contain latex gloves.

MANUFACTURER: PACEART Associates, L.P., Fairfield, New Jersey.

PRODUCT: PACEART CardioVoice Telephone include: a) CardioVoice Speaker Phone, Model No. CVP-1A; b) CardioVoice Trimline Phone, Model No. CVP-1; c) CardioVoice Portable Transmitters (or CardioVoice Phone Portable Option), a compact real-time trainsmitter that can send a patient's real-time electrocardiogram (ECG) to a receiving center at a physician's office or a specialized monitoring service from any location, Model No. CT-1. Recall #Z-227/229-0.

REASON: The devices fall to comply with the performance standard for electrode lead wires and patient cables, 21 CFR 898.

MANUFACTURER: Medtronic Med Rel, Inc., Humacoa, PR.

PRODUCT: Medtronic GEM Implantable Cardioverter Defibrillators: a) Medtronic GEM Model No. 7227Cx Implantable Cardioverter Defibrillator; b) Medtronic GEM Model No. 7229Cx Implantable Cardioverter Defibrillator. Recall #Z-230/231-0.

REASON: Improper P+ wire routing and less than required silicone adhesive insulation on the P+ wire in the connector module.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: Cryolife Allograft Heart Valve: a) Model AVOO; b) Model PVOO. Recall #Z-232/233-0.

REASON: The liver from the donor of the allografts had been diagnosed with cancer.

MANUFACTURER: Hill-Rom Air-Shields, Hatboro, Pennsylvania.

PRODUCT: K-1 Infant Transport Incubators: a) Transport Incubator 1000 - Globetrotter (GT67); b) Transport Incubator 100 - Trailblazer (TB67); c) Transport Incubator 100 - Roadrunner (RR67); d) Transport Incubator 500 - Globetrotter (GT500). Recall #Z-234/237-0.

REASON: The device have a faulty design of the hand ventilator which does not indicate the true pressure in the incubator.

MANUFACTURER: Trinity Biotech plc, Bray, Co. Wicklow, Ireland.

PRODUCT: CAPTIA Rubella-M, Product No. 800-920, used for the detection of IgM antibodies to rubella in human serum as an aid to the diagnosis of recent or current rubella infection. Recall #Z-238-0.

REASON: The High Titre Positive (HTP) Control is reading below the stated Optical Density value of >0.9 for the HTP in the Kit labeling.

MANUFACTURER: Kenpak, City of Commerce, California.

PRODUCT: Sarns 3M Centrifugal Pump, Catalog No. 164275. Recall #Z-240-0.

REASON: Some of the pouches had weak areas near the seams and, post-sterilization, sampling found some pouches had opened up.

MANUFACTURER: Abbott Laboratories, Inc., Morgan Hill, California.

PRODUCT: Abbott ACCLAIM Infusion Pump and Abbott ACCALAIM Encore Infusion Pump Model: 12032-04 and 12237-04. Recall #Z-244/245-0.

REASON: Failure of he temperature compensation sensor circuit can lead to inaccurate delivery.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valves. Recall #Z-248/259-0.

REASON: Donors do not meet current guidelines regarding serodilution of plasma.

CLASS III

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoLife Allograft Heart Valve, Model No. AVOO. Recall #Z-225-0.

REASON: Additional donor information not available at the time of initial donor and tissue review by quality assurance indicates the donor had viral mycocarditis at the time of death.

MANUFACTURER: Datascope Corporation, Cardiac Assist Division, Fairfield, New Jersey.

PRODUCT: Datascope Safety Guidewire, Size .020"x145cm, used in conjunction with the firm's 8 French Intra Aortic Balloon (IAB) Catheters. Recall #Z-239-0.

REASON: Size .030" guidewire was found in the .20" guidewire package

MANUFACTURER: ERBE, Tubingen, Germany.

PRODUCT: Disposable Argon Plasma Coagulation (APC) Probe for Flexible Endoscopy, single use sterile probes: a) Part Number 20132-071; b) Part Number 20132-072. Recall #Z-241/242-0.

REASON: Some of APC Probes may have an incorrect label on the pouch. The pouch has two labels, one international label (four languages) and one US label (English only). The international label may have an incorrect part number and probe diameter. The US label is correct.

MEDICAL DEVICE SAFETY ALERTS:

PRODUCT: PCA I and PCA II Syringe Infusion Pumps, capable of both continuous and intermittent infusion of parenteral fluids with a Patient Controlled Analgesia mode intended primarily for the infusion of analgesics into the patient upon the patient's request by use of the patient button.

Safety Alert #N-003/004-0.
CODE All Baxter PCA Sets without anti-siphon technology used with both the Baxter PCA I Syringe Infusion Pump, Product Code 2L3103 and Baxter PCA II Syringe Infusion Pump, Product Code 2L3104. The affected sets without anti-siphon technology are of the following product codes: 2C9205 - Baxter Tamper Resistant PCA Extension Set, Volume 0.8 mL, Length 60", also marketed under 6566500. 2C9206 - Baxter Tamper Resistant PCA Extension Set, Volume 1.2 mL, Length 96" 2L3507 - Baxter Tamper Resistant PCA Combination Set, Volume 2.5 mL, Length 101".

MANUFACTURER: Baxter Healthcare Corporation, Aibonito, Puerto Rico.
The Aibonito, PR plant manufactures the sets. The PCA I pumps were made by Baxter at their North Reading, MA plant, and the PCA II pumps are made by Baxter at their Singapore plant.
ALERTED BY: Baxter Healthcare Corporation, Round Lake, Illinois, by letter dated November 10, 1999. Firm initiated, ongoing.
DISTRIBUTION Nationwide. QUANTITY 22,800 Pumps. REASON Uncontrolled flow of medication if user improperly loads syringe into PCA pump.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 1, 1999:

CLASS II

MANUFACTURER: Alaris Medical Systems, Inc., San Diego, California.

PRODUCT: IMED Gemini PC-4 Volumetric Infusion Pump and Controller with Version 1.85 Software: a) PC-4 Infusion Pump, Model 1340, 110 volts; b) PC-4 Infusion Pump, Model 1341, 220 volts. Recall #Z-174/175-0.

REASON: Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages.

MANUFACTURER: DeRoyal Surgical, Inc., Powell, Tennessee (component supplier).

PRODUCT: Maxxim Medical Custom Tray Kits containing DeRoyal Light Handle Covers: a) Custom Tray Models, containing DeRoyal Non-Sterile, Model No. 26-011-NS SAF-T-GRIP Light Handle Covers; Custom Tray Models, containing DeRoyal Sterile Model No. 26-012 Light Handle Covers. Recall #Z-211/21-0.

REASON: The light handle covers have the potential to fall off the light handle or split during use.

MANUFACTURER: Zymed Laboratories, Inc., South San Francisco, California.

PRODUCT: Promotional Material for TAB250 Mouse Anti-HER2 [cerbB-2] Antibody.

REASON: Devices were labeled for an intended use not included in the existing 510(k) or PMA

MANUFACTURER: Terumo Cardiovascular Systems Corporation, Ann Arbor.

PRODUCT: 3M Sarns Brand Myocardial Protection Sets in clear plastic trays, indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery: 1) Conducer Cardioplegia Set with MP-4, 4:1 ratio, no recirculation. Catalog #: 165720 Product Order #: 98-0702-0012-0. Several lot numbers; 2) Integrated Cardioplegia Delivery System Blood Mix Cardioplegia Disposable Tubset. Catalog #: 14915 Product Order #: 98-0702-0108-6, several lot numbers; 3) MP-4 Clear Cardioplegia Set Recirculation from the Cannula Connection. Catalog #: 15486 Product Order #: 98-0702-0123-5 several lot numbers; 4) MP-4 Clear Cardioplegia Set Recirculation for the Monitor Module. Catalog #: 15501 Product Order #: 98-0702-0125-0 several lot numbers; 5) MP-4 Blood Cardioplegia Set 4:1 Ratio, Recirculation from the Cannula Connection. Catalog #: 15928 Product Order#: 98-0702-0139-1, lot: W503042. MP-4 Blood Cardioplegia Set 4:1 Ratio, No Recirculation. Catalog #: 16010 Product Order #: 98-0702-0142-5 several lot numbers; 7) MP-4 Clear Cardioplegia Set Filtered Recirculation from the Monitor Module. Catalog #: 16010 Product Order #: 98-0702-0143 Lots: W503020, W503229, W502870, W503454. 8) MP-4 Clear Cardioplegia Set Filtered Recirculation from the Cannula Connection. Catalog #: 16015 Product Order #: 98-0702-0012-0 Lot : W503248. 9) Custom MP-4 Hackensack Medical Center. Catalog #: N/A Product Order #: 98-0702-0153-2 several lot numbers; 10) MP-4 Blood Cardioplegia Set 2:1 Ratio, No Recirculation. Catalog #: 16200 Product Order #: 98-0702-0224-1 Lots: W503621, W502721, W502990; 11) Conducer Cardioplegia Set 4:1 Ratio, No Recirculation. Catalog #: 9457 Product Order #: 98-0702-0344-7, several lot numbers; 12 Conducer Cardioplegia Set with MP-4, 2:1 Ratio, No Recirculation. Catalog #: 9499 Product Order #: 98-0702-0554-1 several lot numbers; 13) Custom MP-4 Conducer Rochester General. Catalog #: N/A Product Order #: 98-0702-0594 several lot numbers; 14) Conducer Cardioplegia Set 1:1 Ratio, No Recirculation. Catalog #: 4414 Product Order #: 98-0702-0630-9 several lot numbers; 15) Conducer Cardioplegia Set with MP-4 8:1 Ratio, No Recirculation. Catalog #: 4459 Product Order #: 98-0702-0656-4 several lot numbers; 16) Custom MP-4 St. Luke's Hospital. Catalog #: N/A Product Order #: 98-0702-0686-1 several lot numbers; 17) Custom Conducer Houston Life Support. Catalog #: N/A Product Order #: 98-0702-0720-8 Lots: W503392, W502832; 18) Custom MP-4 Conducer Hill. Catalog #: N/A Product Order #:98-0702-0723-2 Lots: W503352, W503135, W503710; 19) Custom MP-4 Conducer Presbyterian New York. Catalog #: N/A Product Order #: 98-0702-0756-2 Lots: W503383, W503407, W502928, W503258; 20) Custom 4:1 Hackensack Medical Center. Catalog #: N/A Product Order #: 98-0702-0760-4 several lot numbers; 21) Custom Conducer 8:1 Sacred Heart Hospital. Catalog #: N/A Product Order #: 98-0702-0845-3 several - 3 - lot numbers; 22) Custom MP-4 Conducer CPMC Ozomiser Infusion System. Catalog #: N/A Product Order #: 98-0702-0955-0 Lot: W502788; 23) Conducer Cardioplegia St with Bridge 4:1, No Recirculation. Catalog #: 6376 Product Order #: 98-0702-0966 several lot numbers; 24) Conducer Cardioplegia Set with PM-4 and Bridge 4:1 Ratio, No Recirculation. Catalog #: 6375 Product Order #: 98-0702-0967-5 several lot numbers; 25) Custom MP-4 Conducer B Trap, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-0969-1 Lots: W503910, W502804.; 26) Customized:Bld, Conducer B Trap, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1005-3 Lots: W503356. 27) Conducer Cardioplegia Set Low-Prime 4:1 Ratio. Catalog #: 5852 Product Order #: 98-0702-1022-8 Lots: W503338, W502676, W502919; 28) Custom MP-4 Conducer 8:1 with Brdige Perfusion Products. Catalog #: N/A Product Order #: 98-0702-1118-4 Lots: W503217, W503547; 29) Custom MP-4 Houston Life Support SETA. Catalog #: N/A Product Order #: 98-0702-1154-9 Lots: W503295, W502859.; 30) Custom Conducer 4:1 Bridge University of Iowa. Catalog #: N/A Product Order #: 98-0702-1181-2. Lot W503676.;31) Customized:MUF,BLD, 4:1 Conducer, B Trap, Bridge 4/cs. Catalog #: N/A Product Order #: 98-702-1209-1 several lot numbers; 32) Custom Conducer with MP-4 University of Virginia Medical Center. Catalog #: N/A Product Order #: 98-0702-1210-9 Lot W502691.; 33) Customized: Clear Conducer Reverse Flow D.C. 4/cs. Catalog #: N/A Product Order #: 98-0702-1243-0 Lot: W502858.; 34) Customized: Blood 4:1 MP-4 Coil, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1250-5 several lot numbers; 35) Custom MP-4 with Recirculation UPMC. Catalog #: N/A Product Order #: 98-0702-1205-7 several lot numbers; 36) Customized: Blood 4:1 MP-4 Coil 4/cs. Catalog #: N/A Product Order #: 98-0702-1307-3 several lot numbers; 37) Custom MP-4 4:1 Ratio with Recirculation Bellin Hospital. Catalog #: N/A Product Order #: 98-0702-1420-4 several lot numbers; 38) Custom MP-4 Clear with Recirculation St. Vincent Hospital, Catalog #: N/A Product Order #: 98-0702-1441-0 several lot numbers; 39) Customized: Blood 4:1 Conducer Bubble Trap No Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1458-4 Lot: W503193.; 40) Customized: Blood 4:1 Conducer MP-4 120' Table Line 4/cs. Catalog #: N/A Product Order #: 98-0702-1469-1 Lots: W503552, W503256.; 41) Customized: Blood 2:1 MP-4 Conducer Bridge. Catalog #: N/A Product Order #: 98-0702-1504-5 Lots: W503440, W502772.; 42) Customized: Blood Conducer Bubble Trap 4/cs. Catalog #: N/A Product Order #: 98-0702-1510-2 several lot numbers; 43) Customized: Blood 4:1 Coil Bridge 4/cs. Catalog #: N/A Product Order #: 98-0702-1553-2 Lots:W502999, W502727; - 4 -44) Customized: Blood 4:1 MP-4 B Trap Conducer MUF. Catalog #: N/A Product Order #: 98-0702-1572-2 Lot: W503550; 45) Customized: Clear MP-4 Coil Double Spike, Recirculation. Catalog #: N/A Product Order #: 98-0702-1589-6, several lot numbers; 46) Customized: Blood 4:1 MP-4 Prelief Conducer Low Prime. Catalog #: N/A Product Order #: 98-0702-1494-6 Lots: W503666, W502927, W504233; 47) Customized: Blood 8:1 B Trap Conducer. Catalog #: N/A Product Order#: 98-0702-1672-0, several lot numbers; 48) Customized: Blood 4:1 B Trap Conducer MUF. Catalog #: N/A Product Order #: 98-0702-1679-5, several lot numbers; 49) Customized: Blood Conducer RFDC Isolater Single Spike. Catalog #: N/A Product Order #: 98-0702-1786-8 Lot: W503796; 50) Customized: Blood 4:1 Conducer Bubble Trap Filter. Catalog #: Product Order #: 98-0702-1786-8 Lot: W503796; 51) Customized: Blood 4:1 Conducer Bubble Trap Filter. Catalog #: N/A Product Order #: 98-0702-1789-2, several lot numbers; 52) Customized ICDS Blood Set Bridged Table Line. Catalog #: N/A Product Order #: 98-0702-1798-3 Lots: W503255, W503496; 53) Customized: Conducer B Trap Single Spike MUF. Catalog #: N/A Product Order #: 98-0702-1804-9 Lot: W502716; 54) Customized: Blood 4:1 Bridge MP-4 Coil Prelief 4/cs. Catalog #: N/A Product Order #: 98-0702-1819-7, several lot numbers; 55) Customized: Blood 4:1 Conducer MP-4 Prelief 4/cs. Catalog #: N/A Product Order #: 89-0702-1850-2 several lot numbers; 56) Customized: Blood 4:1 Bridge Coil MP-4 Double Spike 4/cs. Catalog #: N/A Product Order #: 98-0702-1859-3 Lots: W503870, W503595; 57) Customized: Conducer Low Prime 4/cs. Catalog #: N/A Product Order #: 98-0702-1862-7 Lot: W503597; 58) Customized: Blood 4:1 B Trap Conducer Bridge. Catalog #: N/A Product Order #: 98-0702-1877-5 Lots: W503932, W504070, W504144. Recall #Z-214-0

REASON: Seals between the tyvek lid and the clear plastic tray are inadequate resulting in poor seal integrity, thereby compromising the sterility of the devices

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 24, 1999:

CLASS II

MANUFACTURER: Applied Medical Resources, Laguna Hills, California.

PRODUCT: Stealth Surgical Clamps, indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery: a) Model No. A3220; Model No. A3219. Recall #Z-207/208-0.

REASON: The clamps have a potential for misalignment under high pressure which could cause the clamps to release prematurely or to tear the tissue held by the clamp.

MANUFACTURER: Nellcor Puritan Bennett Ireland, Galway, Ireland.

PRODUCT: Nellcor Puritan Bennett 740 Ventilator and 760 Ventilator System. Recall #Z-209/210-0.

REASON: Battery power can deplete when power supply switches voltage due to spikes.

CLASS III MANUFACTURER: North American Sterilization and Packaging, Franklin, New Jersey.

PRODUCT: Spinal Anesthesia Tray, a sterile, disposable, single use device for the administration of spinal anesthesia. Recall # Z-206-0.

REASON: The vials of Tetracaine included on the tray has an expiration date of 4/99, while the trays are dated with an expiration of 8/99. There is a possibility that expired drug could be used resulting in ineffective anesthesia.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 17, 1999:

CLASS II

MANUFACTURER: Sulzer Calcitek Inc., Carlsbad, CA.

PRODUCT: Spline HA-Coated Cylinder Dental Implants (Endosseous Implants), Part # 1852 Recall # Z-130-0.

REASON: 13mm and 15mm implants were interchanged, each size in trays intended (labeled) for the other.

MANUFACTURER: NuMed, Inc., Hopkinton, New York.

PRODUCT: a) Percutaneous Transluminal Angioplasty (PTA) Catheter, Catalog Numbers: PTA-OS253, 303 and 403 b) Z-MED Dilation Catheter, Catalog #PDZ-S c) Z-MED II Dilation Catheter, Catalog Numbers PDS-630, 643 and 655 d) PTA-OS Balloon Catheter, Catalog Numbers: VSB-030 and 040 e) Ghost II Dilation Catheter, Catalog Numbers GII-109, 113, 121, 129, 130, 137, 138, 141. Recall # Z-135/139-0.

REASON: Non-sterility.

MANUFACTURER: Euro/DPC Ltd., Gwynedd, United Kingdom.

PRODUCT: IMMULITE Anti-Thyroglobulin Antibody and IMMULITE Anti-Thyroid Peroxidase Antibody, for in-vitro diagnostic use: a) IMMULITE Anti-Thyroglobulin antibody - 50 Tests; b) IMMULITE Anti-Thyroglobulin Antibody - 100 Tests: c) IMMULITE Anti-Thyroglobulin Antibody - 500 Tests; d) IMMULITE Anti-Thyroid Peroxidase Antibody - 50 Tests; e) IMMULITE Anti-Thyroid Peroxidase Antibody - 100 Tests; f) IMMULITE Anti-Thyroid Peroxidase Antibody - 500 Tests. Recall # Z-154/159-0.

REASON: The sample diluent is non-homogeneous and may produce inaccurate test results.

MANUFACTURER: Sims Deltec, Inc., St. Paul, Minnesota.

PRODUCT: Titanium Venous System (kit), Product Numbers 21-4024 and 21-4024-22 (the Numbers ending in -22 are for exported product); Titanium Venous System (tray), product Numbers 21-4025 and 21-4025-22; Low Profile Titanium Venous System (kit), product numbers 21-4036 and 21-4036-22; Low Profile Titanium Venous System (tray), product numbers 21-4037 and 21-4037-22; Port-A-Cath II Polysulfone/Titanium Venous System (kit), product numbers 21-4052 and 31-4052-22; Port-A-Cath II Polysulfone/Titanium Venous System (tray), product numbers 21-4053 and 21-4053-22; Port-A-Cath II Low Profile Polysulfone/Titanium Venous System (kit), product numbers 21-4082 and 21-4082-22; Port-A-Cath II Low Profile Polysulfone/Titanium Venous System (tray, product Numbers 21-4083 and 21-4083-22; P.A.S. PORT Titanium Venous System (kit), product Number 21-4500; P.A.S. PORT Fluoro-Free Titanium Venous System (kit), product number 21-4505; P.A.S. PORT Fluoro-Free Titanium Venous System (tray), product number 21-4506; P.A.S. PORT T2 Titanium Venous System (kit), product numbers 21-4572 and 21-4572-22; P.A.S. PORT T2 Titanium Venous System (tray), product Numbers 21-4573 and 21-4573-22; Port-A-Cath II Fluoro-Free Polysulfone/Titanium Venous System (tray), product number 21-4653; P.A.S. PORT T2 Fluoro-Free Titanium Venous System (kit), product numbers 21-4672 and 21-4672-22; P.A.S. PORT T2 Fluoro-Free Titanium Venous System (tray), product numbers 21-4673 and 21-4673-22; Port-A-Cath II Low Profile Fluoro-Free Polysulfone/Titanium Venous System (tray), product numbers 21-4683 and 21-4683-22. Recall #Z-160/169-0.

REASON: Fracture of device catheter can result in leaks.

MANUFACTURER: Nellcor Puritan Bennett Ireland, Ltd., Galway, Ireland.

PRODUCT: Revision J Software in the Nellcor Puritan Bennett, 740 Ventilator System and 760 Ventilator System. Recall #Z-170/171-0.

REASON: Software can cause under or over-delivery of oxygen.

MANUFACTURER: Allegiance Healthcare Corporation, Mexicali-Baja Cal, Mexico.

PRODUCT: Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, a sterile non-conductive tubing used with a vacuum-powered suction apparatus. Recall #Z-172-0.

REASON: The outer package seal may not hold, thus the sterility of the product may be compromised.

MANUFACTURER: ALM SA, Parc De Limere, Ardon Orleans Cedex.

PRODUCT: ALM Prismalix (PRX) Ceiling Mounted Surgical Lighting System, used to provide visible illumination of surgical patients and other patient examination procedures: several series numbers. Recall #Z-176/189-0.

REASON: The main arm of the device may fall from the shaft because of missing shaft-retaining clips.

MANUFACTURER: Sterile Recoveries, Inc., Long Beach, California.

PRODUCT: Sri brand of Surgical Procedure Packs, an assembly of finished medical devices and other items used during the preparation and/or performance of surgical/medical procedures: several pack numbers. Recall #Z-190/198-0.

REASON: The devices were labeled and distributed as sterile devices without assurance that they were sterile. The total number of packs sterilized on the load exceeded the maximum validated quantity allowed per load.

MANUFACTURER: NuMed, Inc. Hopkinton, New York.

PRODUCT: Tyshak brand Peripheral Balloon Dilation Catheter, Model 610532, Rated Burst Pressure: 3.5 ATM. Recall #Z-199-0.

REASON: The firm inadvertently attached a Tyshak II balloon to a Tyshak I Catheter. The Tyshak I catheter is labeled with a Rated Burst Pressure of 3.5 ATM. The Tyhsak II balloon has a Rated Burst Pressure of 3.0 ATM. As a result, the balloon could burst prior to the labeled burst pressure.

MANUFACTURER: Pegasus Research Corporation, Santa Ana, California.

PRODUCT: OXY-PEEP Oxygen Diluter Kit, Model P-63000, dilutes oxygen being administered to a patient. Recall #Z-200-0

REASON: The exhalation valve in the mask may stick.

MANUFACTURER: North American Medical Products, Inc., Yorba Linda, California.

PRODUCT: Blood Collection Safety Systems as follows: a) Safe Point M-D, Multi-Draw Needle Cover System, 21 gauge x 11/2" needle, packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. N-621) b) Safe Point M-D, Multi-Draw Needle Cover System, 22 gauge x 11?2" needle, packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. N-622) c) Safe Point VAC Needle Cover System with Blood Collection Needle Vacutainer Holder, 22 gauge x 11/2" needle (some labeled with 1" needle), packaged 150 or 200 pieces per box or individually packaged. (Reorder No. S-621 VAC) d) Safe Point VAC Needle Cover System with Blood Collection Needle and Vacutainer Holder, 22 gauge x 11/2" needle, (some labeled with 1" needle) packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. S-722VAC). Recall #Z-201/204-0.

REASON: Lack of assurance of sterility.

MANUFACTURER: Biocompatible Eyecare, Inc., Norfolk, Virginia.

PRODUCT: Proclear Compatibles Daily Wear Contact Lens. Recall #Z-205-0.

REASON: Leaking blister seal of contact lens packaging compromised sterility.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 3, 1999:

CLASS II

MANUFACTURER: Gambro Renal Care Products, Lakewood, Colorado.

PRODUCT: Dialyzer Control: a) Centrysystem 3 Catalog Nos.: 333103-001 - US 115v Centrysystem 3, BPM; 333103-101 - US 115v Centrysystem 3 Single Needle, BPM; 333103-121 - Euro 240v Centrysystem 3, Single Needle, BPM 333103-201 - US 114v Centrysystem 3+, BPM; 333103-301 - US 115v Centrysystem 3+, Single Needle, BPM; 333104-001 - US 115v Centrysystem 3, No Options 333104-101 - US 115v Centrysystem 3, Single Needle; 333104-121 - Euro 240v Centrysystem 3, Single Needle; 333104-201 - US 115v Centrysystem 3+, No Options; b) Spare Transducer Assembly Catalog numbers: 501036-000 - Arterial/Venous Pressure Transducer Spare Assembly; 501212-003 - Cartridge Holder Spare Assembly; 501249-220 - Transducer Connector Spare Assembly. Recall #Z-064/065-0.

REASON: The dialyzer alarm does not sound when the Maximum Arterial Pressure Alarm Limit is challenged.

MANUFACTURER: Bausch and Lomb Surgical, Clearwater, Florida.

PRODUCT: Soflex UV-Absorbing Silicone PC Intraocular Lenses Model: LI51U & LI61U

REASON: Intraocular lenses may exhibit a cloudy appearance.

MANUFACTURER: St. Shine Optical Company, Ltd., Taiwan, Republic of China.

PRODUCT: LifeStyle MV2 Multifocal, Hydrophilic, Sterile Contact Lenses in blister packs, Rx product. Recall #Z-073-0.

REASON: The contact lenses contain sorbic acid that is not declared on the labeling and my cause a burning sensation in the patient's eye.

MANUFACTURER: Synthes USA, West Chester, Pennsylvania.

PRODUCT: Locking Blot Measuring Device, used to determine the required length of the locking bolt: a) Part number 357.792; b) and Part number 357.113.311. Recall #Z-075/076-0

REASON: The ball that attaches to the measuring slider of the device may detach.

MANUFACTURER: Mathys Medical Ltd., Bettlach, Switzerland.

PRODUCT: Synthes Anatomical Locking Plate System, used to treat fractures of long bones such as the femur: a) Part number 422.340.11; b) Part number 422.341.111; c) Part number 4222.344.111; d) Part number 422.345.111; e) Part number 422.348.111 and f) Part number 422.349.111. Recall #Z-078/083-0.

REASON: The fatigue strength of the plates did not meet the original specification.

MANUFACTURER: Stratec Medical, Eimattstrasse, Switzerland.

PRODUCT: Proximal Femoral Nail (PFN) System, used to ream a hole for the insertion of a femoral neck screw. Recall #Z-084-0.

REASON: The tip of the device may break when it comes in contact with a bent guidewire.

CLASS III

MANUFACTURER: Navarre Biomedical, Ltd., Plymouth, Minnesota.

PRODUCT: Navarre 6 French J-Curve Universal Drainage Catheter, Product, reference number NUD6J, used only in non-vascular drainage procedures, and are intended to be used for abscess, cyst, and other general purpose drainage applications. Recall # Z-023-0.

REASON: The catheter size was incorrectly identified at the tops of the pouch labels of the catheters as 8 French (inside diameter), rather than as the actual size (6 French).