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FDA Recalls

June 7, 2000 - July 26, 2000

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement report as of July 26, 2000

CLASS II

MANUFACTURER: Horizon Medical Products, Manchester, Georgia.

PRODUCT: Neostar Dialysis Catheter Kits and Central Venous Catheter Kits under the following labels:

Neostar Chronic Dual Lumen Catheter Kit - product Code Numbers AC-190K, AC-190KC, AC-190KC-WING, AC-230K, AC-230KC, AC-230KCAL, AC-230KC-WING, AC-230KC-WINGED, AC-270K, AC-270K-WING, AC-280KC, AC-280KC-TV01, AC/DLC-190KC. Neostar Chronic Catheter Placement Kit - Product Code Number AC-K, AC-KC Neostar Acute CAVH Catheter Kit - Product Code Numbers CAVH-1045K, CAVH-1060K, CAVH-945K, CAVH-960K, Neostar Dual Lumen CGV Tunneled Catheter Kit – Product Code Numbers CV-111K, CV-112K, CV-221K, CV-22K, CV-223K, CV-224K,Neostar Triple Lumen CV Tunneled Catheter Kit – Product Code Number CV-331K, Pheres Flow Triple Lumen Catheter Kit – Product Code Numbers CV-332AK, CV-232BK, CV-332K, CV-332K-NEO1, CV-332K-NE02, Neostar Acute Dual Lumen Catheter – Product Code Numbers DLC-400KJ, DLC-500K, DLC-500KC, DLC-500KEC, DLC-500KJ, DLC-511KC, DLC-511KEC, DLC-511KJ, DLC-600K, DLC-600KC, DLC-600KC-AL, DLC-600KC-D101, DLC-600KC-H001, DLC-600KC-SU02, DLC-600KEC, DLC-600K-EC01, DLC-600KJ, DLC-600KLC, DLC-700KC, DLC-700KC-AM01, DLC-700KEC, DLC-700KH, DLC-800K, DLC-800KC, DLC-800KC-AL, DLC-800KC-D01, DLC-800KC-D102, DLC-800KC, DLC-800KC-AL, DLC-800KC-D101, DLC-800KC-D102, DLC-800KC-H002, DLC-800KC-HY02, DLC-800KEC, DLC-800K-EC01, DLC-800KEC-AL, DLC-800KJ, DLC-800KJC, Neostar Peritoneal Insertion Kit – Product Code Numbers PC-K, PC-K-HY01, PC-K-HY02, Neostar Acute Single Lumen Catheter Kit – Product Code Numbers SLFC-1500K, SLFC-2400K, SLJC-1300K, SLJC-170K, SLSC-1500K, SLSC-2000K.

Recall # Z-859/860-0.

REASON: The device package may contain pinholes.

MANUFACTURER: North American Drager, Telford, Pennsylvania.

PRODUCT: Narkomed MRI Anesthesia System, gas machine for anesthesia.

Recall #Z-866-0.

REASON: Fresh gas delivery to the vaporizer is reversed resulting in fresh gas flowing backwards through the vaporizer.

MANUFACTURER: Medtronic Heart valves, Santa Ana, California.

PRODUCT: Medtronic Mosaic® Procine Bioprosthesis: a) Medtronic Mosaic Aortic Valves, Model Nos. 30519, 30521, 30523, 30535, 30527; b) Medtronic Mosaic Mitral Valves, Model Nos. 31025, 31027, 31029, 31031, 31033.

Recall #Z-867/868-0.

REASON: A misinterpretation in measurement of coaptation depth by a technician resulted in the release of out-of specification devices.

MANUFACTURER: Ophthalmic Innovations International, Inc., Claremont, California.

PRODUCT: Intraocular Lenses: Basic Phakic AC-50 refractive lens was the first model produced in 1995 and was subsequently replaced by CAN-60 and ACP-60 in 1996. a) Anterior Chamber Negative CAN-60) lenses for myopic correction (with or without serial numbers assigned); b) Anterior Chamber Positive (ACP-60) lenses for hyperopic correction (with or without serial numbers assigned); c) Phakic 6 Refractive Anterior Chamber Lens for both myopic and hyperopic powers (with/without heparin coating and with/without serial numbers assigned).

Recall #Z-869/871-0.

REASON: The firm failed to obtain an approved IDE (investigational device exemption or PMA (premarket approval).

MANUFACTURER: Steris Corporation, Mentor, Ohio.

PRODUCT: a) OSF-2 Suction Barb Assembly, for use in kit #C1411 QCK;

b) Flow Adaptor Sub-assembly, for use in kit #C1440 QCK;

c) Quick Connect Kit, #C1411, for use on Olympus OSF-2 Flexible Sigmoidoscope.

Recall # Z-872/874-0.

REASON: Metal shavings were found in steris Quick Connect Kits used with endoscopic device.

MANUFACTURER: Ameriwater, Dayton, Ohio.

PRODUCT: Dialysis Reverse Osmosis Water System, single unit/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify portable water for use in making dialystate for hemodialysis: a) Model MROS; b) Model MR01; c) MR02.

Recall #Z-875/877-0.

REASON: Device fails to meet specifications prior to distribution.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 19, 2000:

CLASS II

MANUFACTURER: Bivona Medical Technologies, Gary, Indiana.

PRODUCT: Bivona FlexTend Plus Pediatric Cuffless Tracheostomy Tube. Recall #S-857-0.

REASON: A package contained a standard FlexTend Tube.

MANUFACTURER: Radionics, Burlington, Massachussetts.

PRODUCT: Sterostatic Neurosurgery Planning System, SteroPlan 2.0 and SteroPlan 2.1. Recall #Z-858-0.

REASON: Position errors up to 2.5mm may be observed if the user removes a slice from a CT or MRI image after the image has been fused and a fusion matrix has been generated.

MANUFACTURER: Respironics, Inc., Marietta, Georgia.

PRODUCT: Healthdyne SmartMonitor series Infant Apnea Monitors. Recall #Z-861-0.

REASON: The electrical circuit on the display printed circuit board can become damaged.

MANUFACTURER: Medtronic, Inc., Minneapolis, Indiana

PRODUCT: Medtronic AneuRx Stent Graft System, designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms using an endovascular approach. Recall #Z-862-0.

REASON: Product has the potential for detachment of a 21F-tapered tip nosecone from the catheter.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, Utah.

PRODUCT: Merit Majestic Series, angiographic needle: a) catalog No. AN19U31W; b) Catalog No. AN19U71W; c) Catalog No. K10-01394P. Recall #Z-863/864-0

REASON: The needle hub may be brittle and could fracture during use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 12, 2000:

CLASS I

MANUFACTURER: Ni-Med, Division of Oak Medical Industries, L.L.C., Farmington, Missouri.

PRODUCT: Various Surgical Trays and Procedure Kits containing Sterile Skin Preparations recalled by Clinipad Corporation.

Recall #Z-836-0.

REASON: Class I – Products may be contaminated with bacteria.

Class II – Trays/kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

Recall has been classified as Class I and II:

Kits/trays identified as containing Clinipad Sterile Skin Preparations with Lot Numbers 715786, 805817 and 813873 – Class I.

Kits/trays identified as not containing the above lot numbers, for which the sterility could not be assured – Class II.

MANUFACTURER: Boston Scientific Corporation, Natick, Massachusetts.

PRODUCT: Various Percutaneous Endoscopic Gastronomy Kits containing Clinipad Iodophor PVP Povidone Iodine Antiseptic Swabsticks recalled by Clinipad Corporation.

REASON: Class I - Products may be contaminated with bacteria.

Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

Recall has been classified as Class I and II:

Kits manufactured with the recalled swabsticks, Lot No. 812873 – Class I.

Kits containing swabsticks with Lot Nos. 800468, 807006, 815959, 900359, 818749, 900560, 902649, 905001 and 911138, for which the sterility could not be assured – Class II.

MANUFACTURER: Cook, Inc., Bloomington, Indiana.

PRODUCT: Various Kits containing Iodophor PVP Povidone 1% Solution Antiseptic, 1 fluid ounce recalled by Clinipad Corporation.

Recall #Z-838-0.

REASON: Class I - Products may be contaminated with bacteria.

Class II – Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

Recall has been classified as Class I and II:

Kits with the antiseptic solution, Reorder #394-SB, Lot No. 812422 – Class I.

Kits with antiseptic solutions with Lot Nos. other than 812422, for which the sterility could not be assured – Class II.

MANUFACTURER: Professional Hospital Supply, Inc., Temecula, California.

PRODUCT: Various Custom Procedural Kits containing antiseptic products recalled by Clinipad Corporation.

Recall #Z-839-0.

REASON: The antiseptic products may be contaminated with bacteria.

CLASS II

MANUFACTURER: Cook Urological, Spencer, Indiana.

PRODUCT: Kits/Trays containing recalled Clinipad products, 86 different Cook catalog order numbers. (Note: If necessary, a complete list of devices, catalog and lot numbers can be obtained from the Detroit District Office Recall Coordinator).

REASON: Kits/trays contain Clinipad products labeled as sterile which Clinipad is unable to assure the sterility.

MANUFACTURER: C.R. Bard, Inc., Mentor, Ohio.

PRODUCT: a) Bard Button Device Decompression Tubes; b) Bard Replacement Gastrostomy Device Kit.

Recall #Z-855/856-0.

REASON: The device may be partially occluded (due to mold flash) causing narrowing in the through-hole.

UPDATE

Abbott Plum XL Series Infusion Pumps, Single and triple line infusion pumps utilizing I.V. administration set cassettes, Recall #Z-821/826-0, which appeared in the July 5, 2000 Enforcement should read: Firm-initiated field correction.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 5, 2000:

CLASS I

MANUFACTURER: B. Braun Medical, Inc., Allentown, Pennsylvania.

PRODUCT: Various kits/trays containing products recalled by Clinipad Corporation: Peripherally (Inserted Central Catheter; MLC SLI Peripherally Inserted; Pat 100 Port Access Tray; CISK B. Braun IV Start Kits; CGKM Guidewire Introducer Set; CESKSD Continuous Epidural Anesthesia Tray; Spinocan Spinal Needle; Braun Percutaneous Introducer Set; Burron Microcath Intra. Cath. Placement; Runyon Large Volume Parcentesis Kit; Double Ended Vented Transfer Device; Dressing Change Tray; Dressing Change Kits.

Recall #Z-6091-0.

REASON: The products contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility and/or contain Clinipad products not labeled as sterile for which the company has no assurance that they meet microbiological release specifications.

CLASS II

MANUFACTURER: Valleylab Inc., Boulder, Colorado.

PRODUCT: Valleylab LS1000 Ligasure Vessel Sealing System, for use in general and plastic surgery.

Recall #Z-804-0.

REASON: Grasping ability of device may decrease and. with continued use, come apart.

MANUFACTURER: Bayer Diagnostics Mfg. Ltd., Swords, Co. Dublin, Ireland.

PRODUCT: Bayer Advia 120 Automated Hemotology System, Model 120, a quantitative automated hematology analyzer that provides a leukocyte, differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.

Recall #Z-810-0.

REASON: Higher than expected percentage Reticulocyte counts were received, due to carryover from one sample to another.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CyroValve Allograft Heart Valves.

Recall #Z-813/815-0.

REASON: Donor did not meet current guidelines for serodilution of plasma.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CyroValve Heart Valve Allograft.

Recall #Z-816-0.

REASON: Allograft was collected from a donor who had been incarcerated.

MANUFACTURER: Howmedica Ostenonics Corp., Allendale, New Jersey.

PRODUCT: Howmedica Ostenonics System 12 Crossfire P4 10 polyethylene insert, Catalog number 6352-5-074.

Recall #Z-818-0.

REASON: Size improperly stamped.

MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, New Jersey.

PRODUCT: The Becton Dickinson (Bard Parker) ABG Kits, containing recalled Clinipad products.

Recall #Z-919-0.

REASON: Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

MANUFACTURER: Orion Life Systems, Inc., Wheeling, Illinois.

PRODUCT: Sterile Procedural Trays/Kits packaged by Orion Medical Products, Wheeling, ILL; the trays are packaged in cases of 10, 20, or 30 trays each under the Orion Managed Care, Rusch, Lifenet, ProMed, Grace, Manehim, Starline, and Intermed labels.

Recall #Z-820-0.

REASON: Kits and trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure sterility.

MANUFACTURER: Abbott Laboratories, Morgan Hills, California.

PRODUCT: Abbott Plum Series Infusion Pumps, single and triple line infusion pumps utilizing I.V. administration set cassettes.

Recall #Z-821/826-0.

REASON: Increased number of cassette alarms.

MANUFACTURER: WPC Brands/Wisconsin Pharmacal Company, Jackson, Wisconsin.

PRODUCT: Atwater Carey Ltd. First Aid Kits having the following particular names identifying the uses of the kits: Blister Doc, Pocket Doc, Travel Doc, Cycle Doc, Personal (First Aid), Dayhiker, Backpacker, After The Fall, Walkabout, Family (First Aid), International, Expedition, EMT First Aid, Mountain Rescue, 25 Person, EMT WMI, Sport Pak, Whitewater, Pocket Watertight, Swiftwater Paddler, Wilderness Canoe, Marine Life Pak, Athletes Kit, Athletes Replace Module, Coaches Kit, Coaches Replace Module, Team, American Challenge Team, Team Replace Module, Wound Management Module, First Aid Refill of Antiseptic Towelettes, First Aid Refill – Tincture of Benzoin, Blister Kit, and Marine Waterproof. These kits are labeled as assembled by Wisconsin Pharmacal, Inc., Jackson, WI: Wilderness Medicine Pro 0.5, 1.0, 2.0, and 3.0 First Aid Systems. These first aid kits have the firm name and address of Atwater Carey, Ltd., Salida, CO 81201 on the labels.

The following private label first aid kits were included in the recall: Eagle Creek Traveler, Kwik Tek, Safeway 25 Person Refill, Campmor Hiker, Campmor Guide, and Campmor Advanced.

Recall #Z-827-0.

REASON: Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

MANUFACTURER: Medical Graphics Corporation, St. Paul, Minnesota.

PRODUCT: Medical Graphics Cart, Part #800192, used for diagnostic equipment for checking a patient’s pulmonary function, ECG, and other factors.

Recall #Z-828-0.

REASON: Base of cart could crack allowing caster to come off and cart to topple over.

MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, California.

PRODUCT: Replace/Steri-Oss brand of 4.3 mm Diameter Dental Healing Abutment.

Recall #Z-831-0.

REASON: The wrong size, 4.5 mm D x 3 mm H, endosseous dental implant (healing abutment) was placed into the device packaging labeled for a 4.5 mm D x 5 mm H healing abutment.

MANUFACTURER: Noved Medical, Chatsworth, California.

PRODUCT: Anti-Needlestick Devices: a) B100L UltraSafe Needle Guard; b) CT200 UltraSafe Injection System.

Recall #Z-832/833-0.

REASON: Products were misassembled during production, creating the potential for a needle stick health risk.

MANUFACTURER: Woodside biomedical, Inc., Carlsbad, California.

PRODUCT: Transcutaneous Electrical Nerve Stimulators containing recalled Clinipad Sterile Alcohol Wipes.

Recall Z-840-0.

REASON: Kits contained Clinipad products, labeled as sterile, which lacked assurance of sterility.

MANUFACTURER: Bard Access Systems, Inc., Salt Lake City, Utah.

PRODUCT: Bard/Vas-Cath, Modified Vas-Cath Catheter Repair Kit, Catalog Number 5586000.

Recall #Z-841-0.

REASON: Catheter repair kit connector may detach from repaired catheter extension legs.

MANUFACTURER: Cordis Corporation, Miami, Florida (component manufacturer/responsible firm).

PRODUCT: a) VA Medical Center, Seattle Cardiac Pack; b) Lawrence Memorial Hospital Pericardiocentesis Pack.

Recall #Z-846/847-0.

REASON: Kits/packs contain catheters recalled by Cordis Corporation for possible unexpected fibers.

MANUFACTURER: Optopics Laboratories Corporation, Fairton, New Jersey.

PRODUCT: Sorbic Acid Preserved Saline Solution, in 16-ounce bottles, under the following labels: Fedco, Equate, London Drugs and Life.

Recall #Z-849-0.

REASON: Lack of sterility assurance of Sorbic Acid Preserved saline.

UPDATE

Several recalls which appeared in the June 28, 2000 Enforcement Report incorrectly listed the manufacturer and recalling firm as the same. The following are the correct manufacturers and recalling firms for the noted recalls: 

Z-754/755-0 - SYSMEX CA-100 and SYSMEX CA-500 Automated Coagulation Analyzer.

Manufacturer: Sysmex Corp., Kobe, Japan

Recalling Firm: Sysmex Corporation of America, Long Grove, IL.

Z-785/789-0 – Sarita and Sarita 160 Patient Lift;

Z-790-0 – Maxilift Patient Lift;

Z-791/799-0 - Maximove Patient Lift;

Z-800/802-0 - Marisa Patient Lift

Manufacturer: Arjo Ltd., Glouster, UK

Recalling Firm: Arjo, Inc., Roselle, IL.

CLASS III

MANUFACTURER: Diagnostic Products Corporation, Los Angeles, California.

PRODUCT: Immulite 2000 Rapid TSH L2KRT Kits, a solid-phase, competitive chemilumeninescent enzyme immunometric assay designed for the detection of thyrotropin (thyroid stimulating hormone, TSH) in human serum and as an aid in the clinical assessment of thyroid status.

REASON: The product can yield falsely elevated test results.

MANUFACTURER: Zimmer, Inc., Warsaw, Indiana.

PRODUCT: Zimmer NexGen Knee Option Femoral Size D, Right, Catalog 00-5996-0114-02.

Recall #Z-834-0.

REASON: The buffing residue was left affixed to the underside of the femoral knee component.

MANUFACTURER: Midas Rex, L.P., Fort Worth, Texas

PRODUCT: Medtronic Midas Rex Deserting Tool: a) Medtronic Midas Rex Disecting Tool M-1; b) Metronic Midas Rex Disecting Tool AM-3; c) Medtronic Midas Rex Disecting Tool S4-350; d) Medtronic Midas Rex Disecting Tool S8-350.

REASON: The head of the tool may separate during use.

MANUFACTURER: Binax, Inc., Portland, Maine.

PRODUCT: Binax now Legionella Urinary Antigen Text 22 Kit, for the rapid detection of Legionella pneumophilia seogroup 1 antigen.

Recall #Z-848-0.

REASON: Product has an extended expiration date.

UPDATE

Several recalls which appeared in the June 28, 2000 Enforcement Report incorrectly listed the manufacturer and recalling firm as the same. The following is the correct manufacturer and recalling firm for the noted recall: Z-762-0 - Pentalumen Thermodilution Catheter, Heparin Coated:

Manufacturer: Abbott Laboratories, Salt Lake City, UT

Recalling Firm: Abbot Laboratories, Abbott Park, IL..

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 28, 2000:

CLASS II

MANUFACTURER: Ciba Vision Corporation, Duluth, Georgia.

PRODUCT: MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Lens: a) Model No. U940A, MemoryLens Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular Lens.

Recall #Z-741/742-0.

REASON: Implantation of this lens may cause postoperative inflammation.

MANUFACTURER: Transtracheal Systems, Englewood, Colorado.

PRODUCT: T-9 Scoop Transtracheal Procedure Tray.

Recall #Z-743-0.

REASON: Trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

MANUFACTURER: Sysmex Corporation of America, Long Grove, Illinois.

PRODUCT: SYSMEX CA-1000 and SYSMEX CA-5000 Automated Coagulation Analyzer, used to the clotting times of heparinized patients to adjust their heparin treatment.

Recall #Z-754/755-0.

REASON: Incorrect aPTT (activated partial thromboplastin time) analysis of patient samples which contain elevated levels of fibrinogen or fibrinogen-related products which are not measured by aPTT (fibrinogen monomer) could occur.

MANUFACTURER: McKinley Medical, LLLP, Wheat Ridge, Colorado.

PRODUCT: Walkmed Administration Sets for WalMed Infusion Pumps: a) Catalog #PS-400/300; b) Catalog #EFV-101S; c) Catalog #EFV-101B; d)Catalog #FPS-560.

Recall #Z-756/759-0.

REASON: Defective plastic elbow connector could allow leak or air introduction.

MANUFACTURER: The Kendall Company LP, Mansfield, Massachusetts.

PRODUCT: Curity Spinal Anesthesia Tray; Safe Tap Spinal Anesthesia Tray; Spinal Anesthesia; Saddle Block and Customer Special Spinal Tray.

Recall #Z-766/770-0.

REASON: Spinal anesthesia trays contain recalled Epinephrine Injection USP, 1 ml ampule.

MANUFACTURER: Guidant Corporation, Menlo Park, California.

PRODUCT: Vasoview Dissection/Vessel Harvesting System: a) Vasoview, Part #09331; b) Vasoview Uniport, Part #11344; c) Vasoview Uniport Plus, Part #11346. The VasoView Uniport dissection cannula has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting surgery for arterial bypass.

Recall #Z-771/773-0.

REASON: Sterility may be compromised as evidenced by a loss of package integrity.

MANUFACTURER: GE Marquette Medical Systems, Inc., Milwaukee, Wisconsin.

PRODUCT: Version 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device.

Recall #Z-774-0.

REASON: Due to a software defect, there could be alarm failure.

MANUFACTURER: Radionics, Inc., Burlington, Massachusetts.

PRODUCT: Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove suprious image slices from a scan.

Recall #Z-784-0.

REASON: Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session.

MANUFACTURER: Arjo, Inc., Roselle, Illinois.

PRODUCT: Sarita and Sarita 160 Patient Lift, Non-AC Powered Lift/Transfer System used to transfer patients/residents between beds, chairs and toilets: a )model KKA0400; b) KKA0420-16; c) KKA0401; d) KKB3000-11US; e) KKB3020-16US.

Recall #Z-785/789-0.

REASON: Premature cracking of foot support platform of the lift.

MANUFACTURER: Arjo, Inc., Roselle, Illinois.

PRODUCT: Maxilift Patient Lift, Non-AC powered, used to move patients in a nursing home situation.

Recall #Z-790-0.

REASON: Spring (roll) pin subject to shear in Maxilifts greater than 5 years old.

MANUFACTURER: Arjo Inc., Roselle, Illinois.

PRODUCT: Maximove Patient Lift, Non-AC powered, used to move patients in a nursing home situation: Models KRA0300, MA0510, KMA1004, KMB0810-06, KMB0830-06, KMB4500-12US, KMB6950-12US, KMB6970-12US, KMB6980-12US.

Recall #Z-791/799-0.

REASON: Over depression of the locking spring pin results in the lift arm not locking.

MANUFACTURER: Arjo, Inc., Roselle, Illinois.

PRODUCT: Marisa Patient Lift, Non-AC Powered, used to move weak or highly dependent patients in a nursing home situation: a) Model KGB2000-US, Marisa Complete with Jib, but no Scale; b) Model KGB2100-US, Marisa Complete with Jib and with Scale; c) Model KGA0200.

Recall #Z-800/802-0.

REASON: Jib assembly plunger may not fully engage in the carriage receptacle.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, New York.

PRODUCT: Vitros Cardiology Controls (human serum), for in-vitro diagnostic use only, Catalog #865 0939.

Recall #Z-753-0.

REASON: Cardiology controls gave low values approximately 2 standard deviations below target values.

MANUFACTURER: Stryker Howmedica Osteonics, Allendale, New Jersey.

PRODUCT: Cemented Hip Stem, Catalog #6098-0940.

Recall #Z-760-0.

REASON: Mislabeling – The device is labeled having a 127 degree neck angle when in fact the hip stem actually have a 132 degree neck angle.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, Puerto Rico.

PRODUCT: IMx hCG Calibrators, for in Vitro Diagnostic use. The Imx hCG Calibrators are for the calibration of the Imx Analyzer when used for the quantitative/qualitative determination of human chorionic gonadotropin (hCG) for the early detection of pregnancy.

Recall #Z-761-0.

REASON: The IMx hCG Calibrator lot 55552Q100 rates have decreased over time which may result in elevated control values.

MANUFACTURER: Abott Laboratories, Hospital Products Division, Abott Park, Illinois.

PRODUCT: Pentalumen Thermodilution Catheter, Heparin Coated, Flow-Directed Thermodilution Pulmonary Artery Catheter, Rx device for rapid and accurate measurement of hemodynamic pressure and determination of cardiac output using a cardiac output computer.

Recall # Z-762-0.

REASON: One or more of the lumens in the catheter may be occluded.

MANUFACTURER: Smith and Nephew, Inc., Orthopaedic Division, Memphis, Tennessee.

PRODUCT: Genesis II and Profix Porous Femoral Components, sterile product, packaged one per container for use by an orthopaedic surgeon:

Recall #Z-763-0- Genesis II Femoral Components; several description, part number and lot

Recall #Z-764-0- Profix Femoral Components; several description, part number and lot

REASON: The bead sintering process temperature was insufficient for proper bead/substrate adhesion.

MANUFACTURER: Wesley Jessen Corporation, Des Plaines Illinois.

PRODUCT: FreshLook Toric Soft Hydrophilic Contact Lenses for Astigmatism.

Recall #Z-765-0.

REASON: Mislabeled for corrective power, cylinder and axis.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, New York.

PRODUCT: Cardiology controls (human serum), for in vitro diagnostic use only.

Recall #Z-803-0.

REASON: Cardiology Controls gave low values approximately 2 standard deviations below target.

MANUFACTURER: Nova Biomedical Corporation, Waltham, Massachusetts.

PRODUCT: Lactate Membrane Kit Stat Profile M Series, for use with the Stat Profile M Analyzer. The Stat M. Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, and BUN in serum, plasma, and whole blood to evaluate the acid-base status of patients suspected of having lactic acidosis.

Recall #Z-817-0.

REASON: Extended expiration date.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 21, 2000: 

CLASS II

MANUFACTURER:   Cook Inc., Bloomington, Indiana (tray)  Venetec International, Inc., San Diego, California (Stalock anchoring device)

PRODUCT:      Peripherally Inserted Central Venous Catheter Trays containing Clinipad Cliniguard Protective Dressing Prep.

Recall #Z-811-0.

REASON:      Kits/trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

CLASS III

MANUFACTURER:     Howmedica Osteonics Corporation, Allendale, New Jersey

PRODUCT:       Osteonics Scorpio Posteriorly Stabilized Total Knee:
a) Catalog Number:  71-5105L;  b) Catalog Number 71-5106R c) Catalog Number:  71-5107L; d) Catalog Number 71-5107R;  e) Catalog Number:  71-5109L;  f) Catalog Number: 71-5109R; g) Catalog Number:  71-5111L; h) Catalog Number: 71-5111R:  i) Catalog Number:  71-5113L.

Recall #Z-744/752-0.

REASON:      Product labeling has additional line stating "All Polyethylene" below the product name.

MANUFACTURER:           Gen-Probe, Inc., San Diego, California.

PRODUCT:      Amplified Mycobacterium Tuberculosis, in-vitro diagnostic test kit: a) Part No. 301001, Lot Nos. 909399, 911170, 911172, Exp. Date 08/02/00.

INTERNATIONAL KITS:   b) Part No. 301001E, Lot Nos. 909400, 909410, 912246, Exp. Date 08/02/00;   c) Part No. 301001F, Lot Nos. 909352, 912294, Exp. Date 08/02/00;  d) Part No. 301002J, Lot Nos. 9091352 Exp. Date 04/11/00;  Part No. 301011J, Lot Nos. 909136  Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp. Date 04/11/00;

REASON:      The above reagent experienced a reduced shelf life after being reconstituted.  The reduced shelf life may result in inadequate amplification of some specimens during a test run.  Inadequate amplification may produce false negative results.

MANUFACTURER:    Sunrise Medical HHG, Inc., Somerset, Pennsylvania.

PRODUCT:   DeVilbiss Portable Ultrasonic Nebulizer DC Power Cord.

Recall #Z-809-0.

REASON:                 The wrong DC power cord was supplied with the nebulizer.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 14, 2000:

CLASS II

MANUFACTURER: Bennett X-ray Corporation, Danbury, Connecticut.

PRODUCT: a) Bennett X-Ray Contour Mammography Systems, Model numbers: M-CTR-2000, M-CTR-2000-3P, M-CTR-P, M-CTR-3P; b) Profile Mammography Systems, Model numbers: M-PRO-2000, M-PR02000-3P, M-PRO, diagnostic X-ray devices used in mammography. Recall #Z-739/740-0.

REASON: The units are noncompliant with 21 CFR$ 1020.31 (m) in that the transmission limit 5-cm beyond the plane of the image receptor support device exceeds 0.1 mR per exposure. This can result in the patient receiving unnecessary exposure.

MANUFACTURER: Sim-Med Ltd., United Kingdom.

PRODUCT: Model Gallium Elite and Midi Laser System, for use in pain therapy for animals.

REASON: The device failed to comply with 21 CFR 1010.2, 1010.3, and 1040.10 (f) (6) (I) in that the products lack required certification and identification and compliance with the beam attenuator requirement.

MANUFACTURER: Becton Dickinson & Co., Broken Bow, Nebraska.

PRODUCT: Vacutainer Brain Evacuated Blood Container, partial draw sodium citrate tubes. Recall #Z-778-0.

REASON: Increased platelet activation in partial draw tubes.

MANUFACTURER: Nobel BioCare AB, Gothenburg, Sweden.

PRODUCT: Procedure Tray, Fixture Installation, Catalog #25369, dental handpiece and accessories. Recall #Z-779-0.

REASON: The spring on the connector to the contra-angle handpiece may fracture and come loose.

MANUFACTURER: Alcon Laboratories, Inc., Irvine, California.

PRODUCT: Accurus 200PS Phacoemusification System, Catalog #8065740742, a phacoemulsification system used for opthalmic surgery featuring phacoemulsification, irrigation and aspiration capability, anterior vitrectomy, and diathermy functions. Recall #Z-780-0.

REASON: The low pressure air output (AVGFI) module used with the Alcon Accurus 200PS may unexpectedly drop to a low setting, resulting in low irrigation or infusion pressure during surgery, while vacuum remains active.

MANUFACTURER: Bayer Corporation, Business Group Diagnostics, Mishawaka, Indiana.

PRODUCT: Dexter-ZII Blood Glucose Meter, intended for use in self-monitoring of blood glucose by persons with diabetes: a) Model 3958K2; b) Model 3958N2; c) Model 3969N2. Recall #Z-781/783-0.

REASON: The systems begin to count down prior to the inoculation of the reagent sensor.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 7, 2000:

CLASS II

MANUFACTURER: J.T. Posey Company, Arcadia, California.

PRODUCT: Human Wrist Restraints, used in a hospital setting to restrain the limbs of patients that may be a harm to themselves or attendants: a) Connected Wrist Restraint, Catalog Numbers 2204 and 2205 b) Locking Synthetic Strap, Catalog Numbers 2212 and 2213. Recall #Z-693/594-0.

REASON: The devices were manufactured with materials that did not meet specifications.

MANUFACTURER: Cordis Corporation, Miami Lakes, Florida.

PRODUCT: Cordis French, Mutipacs, Primopacs, Propacs and other modified Angio Catheters and certain Endovascular 6 Fr Supertorque models: a) 6 Fr Supertorque; b) 6 French Supertorque Plus; c) 7 French Supertorque Plus; d) 6 French Plus TL Diagnostic Catheters; e)Multipac Kit (with preceding catheters); f) Propac Kit (with preceding catheters); g) Primopac Kit (with preceding catheters); h) Modified Special Product (with preceding catheters). Recall #Z-695/702-0.

REASON: The catheters may have unexpected fibers in inner lumen which may loosen into the blood.

MANUFACTURER: Continental Medical Laboratories, Inc., Waterford, Wisconsin.

PRODUCT: CML, Inc. Kits and Trays for particular medical procedures. Most of the kits and trays are custom products, manufactured differently for individual customers: several customers. Recall #Z-703-0.

REASON: Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. 

MANUFACTURER: Bard Access Systems, Salt Lake City, Utah.

PRODUCT: Vas-Cath Hemodialysis Catheters (Opti-Flow, Soft-Cell, Flexxicon, Flexxicon II, Trialysis, Vaccess, Niagara, and Hemofiltration. Recall #Z-713/720-0.

REASON: Cracked luer connectors which could cause air embolisms or blood loss.

MANUFACTURER: Cordis Corporation, Miami Lakes, Florida.

PRODUCT: Cordis Savvy PTA Balloon Catheters: several model numbers

REASON: Hub leakage during flushing of catheters because of cracks.

MANUFACTURER: Medtronic PS Medical, Goleta, California.

PRODUCT: Exacta External Drainage and Monitoring System, used for externally draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain and monitoring intracranial pressure due to head trauma. Recall #Z-730-0.

REASON: The device's sterility may be compromised due to loss of package integrity and which may possibly allow bacteria to enter the patient.

MANUFACTURER: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California.

PRODUCT: Pacesetter Trilogy Pulse Generator, indicated for the treatment of bradycardia: a) Trilogy SR 2250 Pulse Generator; b) Trilogy SR+ 2260 Pulse Generator; c) Trilogy SR+ 2264 Pulse Generator; d) Trilogy DC 2308 Pulse Generator; e) Trilogy DC+ 2318 Pulse Generator; f) Trilogy DR 2350 Pulse Generator; g) Trilogy DR+ 2360 Pulse Generator; h) Trilogy DR+ 2364 Pulse Generator. Recall #Z-731/738-0.

REASON: An anomaly with the micropressor integrated circuit was detected. The anomaly behavior includes: Interrogation/programming difficulties, including the presence of dashes (---) on the programmer screen for some parameter values after interrogation; Unexpected rate variations: Abnormally high battery current drain; Mode change. 

CLASS III

MANUFACTURER: Merge Technologies, Inc., West Allis, Wisconsin.

PRODUCT: Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers 006-04100-00, 006-04100-01, 006-0411-00S, 006-04100-01S, and 006-04100-02. Recall #Z-721/725-0.

REASON: Warning label which limits product use was omitted from the cable of the video units.

MANUFACTURER: Medicore, Inc., Hialeah, Florida.

PRODUCT: U-100 Insulin Single Use Syringes, 29 G X 1/2 inch and U-100 Insulin Single Use Syringes, 28 G X 1/2 inch. Recall #Z-726/727-0.

REASON: Mislabeled volume on outer shelf cartons, device package is correct.

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

PRODUCT: Alycon Reagent Probe LN 05D44-01. Recall #Z-729-0.

REASON: The box labeled as containing a Reagent Probe actually contained an ISE probe.
 

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