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FDA Recalls

April 5, 2000 - May 31, 2000

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 31, 2000:

CLASS I

MANUFACTURER: Gambro Renal Products, Lakewood, Colorado.

PRODUCT: All Clini-Kits and COBE Clinical Kits containing Antiseptic Products recalled by Clinipad Corporation. Recall #Z-687-0.

REASON: The antiseptic products may be contaminated with bacteria.

MANUFACTURER: Lee Medical International, Inc., Harahan, Louisiana.

PRODUCT: Various Dialysis Kits containing antiseptic products recalled by Clinipad Corporation. Recall #Z-688-0.

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 for which the firm was unable to identify the code and lot numbers of Clinipad products - Class I. Kits identified as containing Clinipad Code Number 9153, Lot Number 911636 and Code Number 1261, Lot Number 914953, for which the sterility could not be assured - Class II.

MANUFACTURER: Vital Signs, Inc., Totowa, New Jersey.

PRODUCT: Broswlow/Hinkle Kits containing Antiseptic products recalled by Clinipad Corporation. Recall #Z-689-0.

REASON: The antiseptic products may be contaminated with bacteria.

MANUFACTURER: Jones-Zylon Company, West Lafayette, Ohio.

PRODUCT: Various I.V. Starter and Hospital Administration Kits containing Antiseptic products recalled by Clinipad Corporation: Brown Co. I.V. Start Kit, Part #561098, 100 per case; Doctors/Mass I.V. Start Kit, Part #561696, 100 per case; Hardin Memorial Hospital, O.B. Kit, Part #561715, 8 per case; Marion Medical Center I.V. Start Kit, Part #561730, 100 per case; Toledo Hospital I.V. Start Kit, Part #561635, 50 per case; Fostoria Hospital I.V. Start Kit, Part #461751, 100 per case; Bryan Infant Kit, Part #561771, 20 per case; Promedica I.V. Start Kit, Part #561816, 100 per case; Pomerene I.V. Start Kit, Part #5610941, 100 per case; Wilson Memorial Newborn, Part #5628354, 12 per case; Surgery Center I.V. Start Kit, Part #562836, 100 per case; Bixby Baby Kit, Part $562843, 12 per case; Fulton Co. IV Start Kit, Part #568053, 100 per case; Tolfree Hospital, Infant Kit, Part #568600, 10 per case; Adams County I.V. Start Kit, Part #562041, 100 per case; Jefferson Memorial Newborn Kit, Part #568662, 9 per case; and Jefferson Memorial O.B. Kit, Part #568665, 10 per case. Recall #Z-690-0.

REASON: The antiseptic products may be contaminated with bacteria.

CLASS II

MANUFACTURER: Drummond Scientific, Broomall, Pennsylvania.

PRODUCT: Capillary Dispensers. (Capillary tube or capillary blood collection tube), intended to be used by medical professionals to collect blood from a patient and to dispense the blood into a test cartridge. Recall #Z-614-0.

REASON: The device is subject to elevated potassium results (a positive potassium bias of about 0.8mM) while testing capillary blood samples.

MANUFACTURER: Arrow Intl., Inc., Reading, Pennsylvania.

PRODUCT: Vennous Catheter Kits (central, percutaneous, and single lumen) and One Arterial Kit containing products recalled by Clinipad Corporation.

REASON: Kits contain Clinipad products (alcohol prep pads, bezoin tinet swabssticks, povidone iodine prep pad, povidone iodine ointment, and alcohol swabsticks) labeled as sterile for which Clinipad is unable to assure their sterility.

MANUFACTURER: Invacare Corporation, Elyria, Ohio.

PRODUCT: Power Wheelchairs: a) Power Tiger; b) P7E with duel battery box upgrade only, c) 9M; d) Excel; e) PMC: f) Ranger II. Recall #Z-705/710-0.

REASON: Wheelchairs may catch fire due to improper wiring harnes configuration.

MANUFACTURER: North American Medical Products, Inc., Albany, New York.

PRODUCT: Blood Collection Needle with Sheath, 21 GA. x 1" Needle, single use only, sterile: Unless package is opened or damaged.

REASON: Package integrity - lack of assurance of sterility.

MANUFACTURER: Medcare Medical Group, Inc., East Swanzey, New Hampshire.

PRODUCT: Various procedure trays containing including the following: Central Line Dressing, Midline/PICC Line Support, Subclavian On/Off, Dressing Change, Nerve Block, VAD Access, General Purpose Instrument, I.V. Start, Suture Removal, Ventriculostomy, Wound Care, Urethral/Foley Catheter, Catheter Care, under the Medicare and 14 private labels: Medical Marketing, Catalog #DK7-7178; Capital Medical Inc., Catalog #CMI-2001; UHS?HCI St. Louis, Catalog #DF8-8047; Owens and Minor (Touro Infirmary-label), Catalog #DP2-2161; Rockwell Medical, Catalog #RW-1020, 2011, 2100; Modern HomeCare, Catalog #DK7-0312; Patients Choice (Hospice or SpectraCare label). Catalog #DN7-7099; Children's Hospital Medical Center, Catalog #DP2-2052; Medtronic PS Medical, Catalog #46155. Recall #Z-712-0.

REASON: Procedure kits contain recalled Clinipad antiseptic products.

MEDICAL DEVICE SAFETY ALERT

PRODUCT Castle Series 200 Steam Sterilizer (Powerclave), intended for sterilizing medical devices for use in hospitals and health care facilities: a) Castle Model 222: Gravity Steam Sterilizer, Double Door; b) Castle Model 233: Vacuum Steam Sterilizer, Single Door. Safety Alert #N-015/016-0. CODE Serial #s range from 97A58318 thru 99M60565. The first 3 characters represent the year and month. (A-January, etc.) The last five numbers are consistent with pressure vessel identification. NOTE: There are sterilizers within this serial number range that are NOT affected by this field correction. However, those sterilizers have different model numbers than those subject to this safety alert. 

MANUFACTURER Getine/Castle, Inc., Rochester, New York. ALERTED BY Manufacturer, By letter on April 12, 2000 DISTRIBUTION Nationwide and international. QUANTITY 286 sterilizers were distributed. 

REASON Sterilizer door opened during sterilization cycle due to damaged door hook.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 24, 2000:

CLASS I

MANUFACTURER: Allegiance Healthcare Corporation, Custom Sterile Divis, McGaw Park, Illinois.

PRODUCT: Sterile Custom Surgical & Procedure Kits/Trays packaged by Allegiance Healthcare Corp., McGaw Park, IL, under three divisions, Custom Sterile Division, Medsurg/Isolyser Division and Custom Products/PBDS Division. These kits, containing antiseptic products recalled by Clinipad Corporation, are packed according to the special order requirements of the customer. Recall #Z-604-0.

REASON: Class I - Kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria. Class II - Kits/trays contain Clinipad products for which the sterility could not be assured. Recall has been classified as Class I and Class II Devices packaged and distributed by Allegiance Healthcare Medsurg and PBDS Division - Class I. Kits/Trays packaged and distributed by the firm's Custom Sterile Division, which was able to identify the Clinipad products and lots used, for which the sterility could not be assured - Class II.

MANUFACTURER: Medical Components, Inc., Harleysville, Pennsylvania.

PRODUCT: Ash Split Cath II Hemodialysis Catheter containing triCitrasol: a) Model No. ASPC24-2T; b) Model No. APC28-2T; c) Model No. ASPC32-2T; d) Model No. ASPC36-2T; e) Model No. ASPC55-2T; f) Model No. TRAY552-2T; g) Model No. TRAY553-2T; h) Model No. TRAY593-2T; I) Model No. TRAY594-2T. Recall #Z-669/677-0.

REASON: TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA.

MANUFACTURER: Medical Components, Inc., Harleysville, Pennsylvania.

PRODUCT: Medcomp Bio-Flex Catheter (CS100) containing triCitrasol, Model No. BFR-6T. Recall #Z-678-0.

REASON: TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA.

MANUFACTURER: Cytosol Laboratories, Inc., Braintree, Massachusetts.

PRODUCT: TriCitrasol (46.7% trisodium citrate), Citra and Medcop part/catalog #PN6030. Recall #Z-679-0.

REASON: TriCitrasol may be inadvertently administered into patients at full strength (46.7) percent) rather than being diluted as inteded. In addition, the devices were distributed without appropriate clearances from FDA.

MANUFACTURER: Cytosol Laboratories, Inc., Braintree, Massachusetts.

PRODUCT: TriCitrasol Anticogulant Sodium Citrate Concentrate 46.7% Trisodium Citrate, 30 mL glass vial, used to keep bloodliness open. Recall #Z-692-0.

REASON: TriCitrasol may be inadvertently administrated into patients at full strength (46.7%) rather than being diluted as intended. In addition, the device was distributed without appropriate clearances from FDA.

CLASS II

MANUFACTURER: Roche Diagnostics GmbH, Mannheim, Germany.

PRODUCT: Boehringer Mannheim Cretinine Jaffe Reagent, for the quantitative determination of creatinine in serum, plasma, and urine. Recall #Z-680-0.

REASON: Product does not meet the specifications for bilirubin interference.

MANUFACTURER: FISMA, Inc., Salt Lake City, Utah.

PRODUCT: Model Elite/Corium Laser Systems, for use in dermatology, dentistry ophtalmology, ENT, etc. Recall #Z-683-0.

REASON: If a single component on the light feedback circuit were to fail, the laser would emit full power at any power setting.

MANUFACTURER: Becton Dickinson, BD Medical Systems, Franklin Lakes, New Jersey.

PRODUCT: B-D 1 ml Safety-Lok Insulin Syringe, 29G 1/2 Ultrafine Needle, Reorder No. 329464. Recall #Z-684-0.

REASON: Product was marked in ml scale instead of insulin units.

MANUFACTURER: Seachrist Industries, Inc., Anaheim, California

PRODUCT: Infant and Pediatric Ventilators, intended for neonatal, infant, and pediatric ventilation: a) Model IV-100B/Model IV-200 infant and Pediatric Ventilator; b) Model IV-100B/Model IV-200 SAVI System (Ventilator with Synchronized Assisted Ventilation of infants Module). Recall #Z-685/686-0.

REASON: The metallic battery brackets can become dislodged from the inside back cover of the ventilator and contact the main circuit board assembly of the ventilator's operating system.

CLASS III

MANUFACTURER: Roche Diagnostics GmbH, Mannheim, Germany.

PRODUCT: Roche Reflotron Plus Analyzer, Catalog #747461, a bench top photometric chemistry analyzer for clinical use, which utilizes reagent strips for testing of multiple analytes. Recall #Z-668-0.

REASON: There is a potential for erroneous results due to a loose screw in the lower heating plate, which affects the lower heating unit of the analyzer.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 17, 2000:

CLASS I

MANUFACTURER: Medline Industries, Inc., SPT Division, Waukegan, Illinois

PRODUCT: Medline SPT Surgical and Procedure Kits and Trays containing recalled clinipad products. Recall #Z-524-0

REASON: Kits contain clinipad antiseptic products that may be contaminated with bacteria.

MANUFACTURER: Medikmark, Inc., Waukegan, Illinois.

PRODUCT: Sterile Surgical and Procedure Kits/Trays distributed under labels identifying: Medikmark Inc., 900 Asbury Drive, Buffalo Grove, IL 60089; Medikmark, Inc., 3600 Bur Wood Drive, Waukegan, Il 60085; Distributed by Maxxim Medical, Case Management Division, Clearwater, FL 34622; Manufactured for R&J Medical Supply, Milwaukee, WI 53223; Distributed by Triad Medical, Laguna Hills, CA 92653. Recall #-525-0.

REASON: The kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria.

MANUFACTURER: Clinipad Corporation, Norwich, Connecticut.

PRODUCT: Various Sterile Procedure Kits and Trays containing antiseptic products that may be contaminated with bacteria.

REASON: Class I - Antispetic products may be contaminated with bacteria. Class II - Kits/trays contain products for which the sterility could be asured.

Recall has been classified as Class I and II: 

Kits/trays manufactured and listed with specific lot numbers - Class I. Kits/Trays not specifically listed with lot numbers, but which contain products for which the sterility could not be assured - Class II.

MANUFACTURER: KenMex, Tijuana, Mexico, Kendall Healthcare, Chatswork, California.

PRODUCT: Various sterile procedure kits containing antiseptic products recalled by Clinipad Corporation under the Kendall brand (Curity, Kenguard and Sage); and private label: Allegiance, Source and Respiratory Support Products, Inc. (RSP). Recall #Z-605-0

REASON: Class I - Kits contain antispectic products that may be contaminated with bacteria. Class II - Kits contain Clinipad antiseptic 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 antiseptic product (assigned Kendall Lot Numbers 9348004 and 9355015) - Class I 
Kits not containing those specific lots, but which contain Clinipad products for which the sterility could not be assured - Class II.

CLASS II

PRODUCT: Recall #Z-484-0 which appeared in the April 19, 2000 Enforcement Report should read: PRODUCT: Total B-hcG Controls, for in-vitro diagnostic use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 10, 2000:

CLASS I

MANUFACTURER: Cypress Medical Products, Ltd. McHenry, Illinois.

PRODUCT: Cypress Medical Products Sterile Procedure Kits and Tray containing antiseptic products recalled by Clinipad Corporation. Recall #Z-522-0.

REASON: The antiseptic products may be contaminated with bacteria.

MANUFACTURER: Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.

PRODUCT: Various Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation: ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with T-Fasteners, Complete Kit, 14 French (List #00227); ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with T-Fasteners, Complete Kit, 18 French (List #00238); ROSS Flexiflo Introducer Gastrostomy Kit with Brown/Mueller T-Fastener Set, Complete Kit, 18 French (List #50190); ROSS Inverta-PEG Pull Technique Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #52002); ROSS Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List 52354); ROSS Flexiflow Versa-PEG Gastrostomy Kit, Complete Kit, 22 French (list #50520); ROSS Flexiflo Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #51492) [Obsolete]. Recall #Z-523-0.

REASON: Kits contain Clinipad antiseptic products which may be contaminated with bacteria.

CLASS II

MANUFACTURER: Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.

PRODUCT: Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation: ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 16 French (List #50724); ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 20 French (List #50738). Recall #Z-523-0.

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

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia

PRODUCT: Heart Valve Allograft Models AVOO, PVOO, AV05.

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

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

PRODUCT: Hemodialysis/Apheresis Trays containing recalled Clinipad products. Recall #Z-632-0.

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

MANUFACTURER: LSL Industries, Inc., Chicago, Illinois

PRODUCT: LSL Sterile Mid-Stream Urine Specimen Kit, 120 ml, containing recalled Clinipad product. Recall #Z-633-0

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

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

PRODUCT: Deltec Procedural Tray (containing recalled Clinipad products) for use with CliniCath Peripherally Inserted Catheters, Product Numbers 21-2501-01 and 21-2515-01; Deltec CliniCath Peripherally Inserted Catheters, with Tray, Product Numbers 21-2508-01, 21-2509-01, 21-2510-01, 21-2511-01, 21-2512-01, and 21-2513-01. Recall #Z-634-0.

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

MANUFACTURER: Aspect Medical System, Inc., Natick, Massachusetts.

PRODUCT: Zipprep Electrode Starter Kits containing Clinipad Alcohol Antiseptic Swabsticks, intended for use with EEG monitoring Systems. Recall #Z-635-0.

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

MANUFACTURER: Physician Industries Manufacturing, West Valley City, Utah.

PRODUCT: General Procedure Kit. Recall #Z-637-0.

REASON: Distributed kits had positive bioburden test results after Eto Sterilization.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valve, Model AVOO and PVOO. Recall #Z-638/639-0.

REASON: Donor did not meet current guideline regarding serodilution of plasma.

MANUFACTURER: Shaoxing Life Surgical Dressing Company, Ltd., Zhejiang Prov. Shaoxing County, China.

PRODUCT: Hermitage Eye Pads, Sterile 2 1/8" x 2 5/8", Product of China. Sterilized in the U.S.A. for use as a bandage over the eye for protection or absorption of secretions: a) Item No. EP-1600; b) Item No. EP-2000. Recall #Z-640/641-0.

REASON: Product was not sterilized and incorrectly transferred to released inventory without being gamma sterilized.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valve, Models PV00, AV00, Av40, MV10 PV05. Recall #Z-642/646-0.

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

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

PRODUCT: Disposable Coronary Control Syringe, 20mL, Catalog #K01-04072. Recall #Z-647-0.

REASON: Syringes were shipped to customer prior to terminal sterilization processing.

MANUFACTURER: Bio-Vascular, Inc., St. Paul, Minnesota.

PRODUCT: Flo-Rester Sizer Pack (of blood vessel sizers), used to determine the internal diameters of arteries and veins: Catalog Numbers: a) FRSZPKO5; b) FRSZ400; c) FRSZ300; d) FRSZ250; e) FRSZ200; f) FRSZ150. Recall #Z-648/653-0.

REASON: The bulb of the device may loosen and become detached from the shaft.

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

PRODUCT: VACUTAINER Urine Collection Kit for Midstream Specimens containing recalled Clinipad products. Recall #Z-659-0.

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

MANUFACTURER: Wilson-Cook Medical, Inc., Winston-Salem, North Carolina.

PRODUCT: FLOW-20, USED AS A GASTROINTESTINAL FEEDING TUBE: a) Flow-20-Push; b) Flow-20-Pull; c) Flow-20-Pull-S. Recall #Z-660/662-0.

REASON: Kits may contain a larger external bumper, which may not properly secure the feeding tube.

MANUFACTURER: Siemens AG, Erlangen, Germany.

PRODUCT: Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall #Z-664/665-0.

REASON: Patients who are registered on the MRI systems with birth dates of January 1, 2000 or later will be misinterpreted by the software to have been born in 1900.

MANUFACTURER: Diagnostic Chemicals Ltd., Charlottestown, PE, Canada.

PRODUCT: Product insert for Acetaminophen (Enzymatic Rate) Reagent, used for the quantitative determination of Acetaminophen in serum, Catalog #502-13. Recall #Z-667-0.

REASON: The "Product Insert" does not contain information on interference from N-acetylcysteine (NAC), the drug of choice for treating acetaminophen overdose.

UPDATE 

Abbott ARCHITECT I System with Software Version 1.0 Processing Module, List No. 08C89-00- 1, designed to perform automated immunoassay tests based on the use of Chemiluminescent Microparticle Immunoassay (CMIA) detection technology. Recall #Z-611-0, which appeared in the May 3, 2000 Enforcement Report should read: RECALLED BY: Manufacturer, by telephone on February 25, 1999.

CLASS III

MANUFACTURER: Biomerica, Inc., Newport Beach, California.

PRODUCT: GAP IgG Helicobacter Pylori Enzyme Immunoassay Kit, for the qualitative detection of IgG specific antibodies to helicobacter pylori in human serum. Recall #Z-610-0.

REASON: The stability parameters were starting to draft and would be out-of-specification before the expiration date.

MANUFACTURER: Manufacturas Frontera Norte SA de CV, CD Juarez, Mexico.

PRODUCT: Endoscopic Blunt Dissecting Instrument, used to probe or move organs during surgery. Recall #Z-636-0.

REASON: Tip separated from body while in use.

MANUFACTURER: Nicolet, Madison, Wisconsin.

PRODUCT: Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers: 006-04100-00, 006-04100-01, 006-04100-00S, 006-04100-01S and 006-04100-02. Recall #Z-654/658-0.

MANUFACTURER: Eastman Kodak Company, Windsor, Colorado.

PRODUCT: Kodak Oncology Film, identified as ESFLM film, 35 x 43 cm, Catalog No. 8715757. Recall #Z-663-0.

REASON: Graphic Arts film was slit, chopped, and packaged as Oncology X-ray Film.

MANUFACTURER: Oxoid Ltd., Basingstoke Hants RG248PW, United Kindom.

PRODUCT: Ampicillin/Sulbactam 10/10 mcg Antimicrobial Susceptibility Test Disk, packaged 50 disks per box, intended for use in the standardized disk susceptibility test and is the recommended method of performing antimicrobial disk diffusion testing. Recall #Z-666-0.

REASON: The zones of inhibition obtained were below the acceptable zone diameter of the NCCLS Standard for Antimicrobial Disk Susceptibility Tests.

MEDICAL DEVICE SAFETY ALERTS: 

PRODUCT Abbott Ambulatory Infusion Manager Plus Single-Channel Infusion Pump, Five types of programming options available for TPN, pain management, intermittent, variable time and contiuous delivery of medications and nutritional fluids. Safety Alert #N-014-0. CODE List #13967, Serial Numbers 12300001/12320000. 

MANUFACTURER Abbott Laboratories, Inc., San Diego, California. ALERTED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter date, by letter on March 2, 2000. DISTRIBUTION Nationwide. QUANTITY 15,947 units were distributed. 

REASON There is a possibility that medication therapy may be missed on March 1, 2000, due to the leap year, if the pumps were not appropriately reprogrammed on March 1, 2000.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 3, 2000:

CLASS II

MANUFACTURER: Promed Kits, Davis, California.

PRODUCT: Pro Med Kits assembles first aid kits on key chains each containing a CLINIPAD Alcohol Prep, antiseptic. Recall #Z-575-0.

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

MANUFACTURER: Ballard Medical Products, Draper, Utah.

PRODUCT: PEG Kits, T-J Tube kits, Epidural Trays, Spinal Procedure Universal Block trays, Paracentesis Trays containing recalled Clinipad products: Models 0150-14, 0150-20, 0150-24, -160-14, 0160-20, 0160-24, 0260-16, 0260-18, 0260-22, 182125, 182131, 182184, 182224, 182229, 182230, 18236, 18259, 19283, 18289, 18668, 18178, 18184, 18202, 60432, 60433. Recall #Z-577-0.

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

MANUFACTURER: CooperSurgical, Inc., Shelton, Connecticut.

PRODUCT: Procedure kits containing recalled Clinipad products: a) LEEP Redikit - Product Number: 6060; b) Hysteroscopy Kit - Product Number:6160; c) Cervical Block Kit - Product Number: 6161. Recall #Z-578-0.

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

MANUFACTURER: The Kendall Co. LP, Seneca, South Carolina.

PRODUCT: T. E. D. Sequential Compression Sleeves: a) Model No. 5329 SCD Blue Sleeves, Knee Length; b) Model No. 5330 SCD Blue Sleeves, Thigh Length Medium; c) Model No. 5345 SCD Blue Sleeves, Thigh Length Small; d) Model No. 5480 SCD Blue Sleeves, Thigh Length Large. Recall #Z-579/582-0.

REASON: The compression sleeves may have occluded airway tubes.

MANUFACTURER: Chase Medical, Inc.,

PRODUCT: 24 French Aortic Arch Cannula, indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass: a) Model No. ANC-S824S b) Model No. ANC-P824S; c) Model No. ANC-L824S; d) Model No. ANC-S824S-NF; e) Model No. ANC-P824S-NF f) Model No. ANC-L824-NF; g) Model No. AWC-S824S h) Model No. UACs824S; I) Model No. UACP824S; j) Model No. UACL824S; k) Model No. FACL824; l) Model No. UWCS824. Recall #Z-590/601-0.

REASON: The cannula may leak under certain flow and device manipulation conditions.

MANUFACTURER: Bayer Corporation, Business Group Diagnostics, Middletown Manufacturing Plant, Middletown, Virginia.

PRODUCT: Bayer SETpoint Unconjugated Estriol Reagent (uE3) for Bayer Immuno 1 System, an assay to measure unconjugated estriol in human serum. Recall #Z-609-0.

REASON: The device is associated with a failure to calibrate the assay on the system RSS limits, erratic quality control results, and a calibration interval of less than seven days.

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

PRODUCT: ARCHITECT I System with Software Version 1.0 Processing Module, List No. 08C89-00-1, designed to perform automated immunoassay tests based on the use of Chemiluminescent Microparticle Immunoassay (CMIA) detection technology. Recall #Z-611-0.

REASON: Software errors can potentially result in printed Patient Report to incorrectly associate tests results with patients Ids under certain conditions.

MANUFACTURER: Hitachi Instruments Division, Ibari-Ken, 312 Japan.

PRODUCT: Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000. Recall #Z-612-0.

REASON: There is a potential for mismatch of sample identification information and results on all versions of software.

MANUFACTURER: Roche Diagnostic Corporation, Indianapolis, Indiana.

PRODUCT: Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes. Recall #Z-613-0.

REASON: There is a potential for mismatch of sample identification information and results on this version of software.

MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, Indiana.

PRODUCT: LCS Total Knee System - PS Tibial Insert: a) Small size, Catalog Nos. 1781-20-100, 1781-20-125, 1781-20-150, 1781-20-175, 1781-20-200; b) Small Size, Catalog Nos.1781-21-100, 1781-21-125, 1781-21-150, 1781-21-175, 178-21-200; c) Standard size, Catalog Nos. 1781-22-100, 1781-22-125, 1781-21-150, 1781-22-175, 1781-22-22; d) Standard + Size, Catalog Nos. 1781-23-100, 1781-23-125, 1781-23-150, 1781-23-175, 1781-23-200;

e) Large Size, Catalog Nos. 1781-24-100, 1781-24-125, 1781-24-150, 1781-24-175, 1781-24-200; f) Large + Size, Catalog Nos. 1781-25-100, 1781-25-125, 1781-25-150, 1781-25-175, 1781-25-200. Recall #Z-616/621-0.

REASON: The devices can cause the escape of fluid from blood vessels into the tissues or a cavity and cause knee pain.

MANUFACTURER: Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan.

PRODUCT: Sarns MP-6 Integrated Cardioiplegia Sets, used for delivery of temperature controlled cardioplegia solutions to the heart during cardiopulmonary bypass surgery: a) MP-6 Integrated Cardioplegia Set, Catalog No. 4972, Lot No. 98-0702-1659-7 (1:1 Ratio, No Recirculation); b) MP-6 Integrated Cardioplegia Set, Catalog No. 4973, Lot No. 98-0702-1660-5 (2:1 Ratio, No Recirculation); c) Mp-6 Integrated Cardioplegia Set, Catalog No. 4974, Lot No. 98-0702-1661-3 (4:1 Ratio No Recirculation); d) MP-6 Integrated Cardioplegia Set, Catalog No. 4975, Lot No. 98-0702-1662-1 (4:1 Ratio, With Bridge, No Recirculation); e) MP-6 Integrated Cardioplegia Set, Catalog No. 4976, Lot No. 98-0702-1663-9 (8:1 Ratio, No Recirculation); f) MP-6 Integrated Cardioplegia Set, Catalog No. 4977, Lot No. 98-0702-1664-7 (4:1 Ratio, No Recirculation). Recall #Z-622/627-0.

REASON: Holes in the mylar side of the passdown line pouch are inadequate which results in compromising the sterility of the device.

CLASS III

MANUFACTURER: DeRoyal Industries, Powell, Tennesse.

PRODUCT: a) Ankle Contracture Boot and Boot Sole Accessory, Model Numbers: 4300, 4301, 4302, 4305, 4306, and R4307; b) Boot Sole Accessory #4300/05WK. Devices intended to stabilize the ankle after trauma or injury. Recall #Z-532/533-9.

REASON: The device fails to bear a caution label that it is not intended for weight bearing purposes, and as a result, the bolt on the bottom of the boot holding the boot sole in place, cracks and breaks, causing the sole to dislodge.

MANUFACTURER: Cyberonics, Inc., Inc., Houston, Texas.

PRODUCT: Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for the treatment of epilepsy.

REASON: The label insert sheets were printed with the incorrect lot number.

MANUFACTURER: Meridian Diagnostics, Inc., Cincinnati, Ohio.

PRODUCT: IMMUNOCARD H. Pylori, for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Recall #Z-576-0.

REASON: Variations of the positive control and test ports may lead to invalid results.

MANUFACTURER: Roche Diagnostics GmbH, Mannheim, Germany

PRODUCT: Boehringer Mannheim Systems Creatinine Plus, for the quantitative determination of creatinine in serum, plasma and urine. a) Catalog No. 1775685; b) Catalog No. 1775642; c) Catalog No. 1775677. Recall #Z-606/608-0.

REASON: These lots exhibit positive interference from lactate. The lactate interference is undetectable in samples containing normal levels of lacatate.

MANUFACTURER: MJS Healthcare, Ltd., Barton, Bedfordshire, England.

PRODUCT: Carolon Trinity Pneumatic Pump, Model 480000. Recall #Z-615-0.

REASON: A plug portal area with a hairline crack and recession of receptor prong into casing could result in a potential fire hazard within the cord.

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

CLASS I

MANUFACTURER: Metrex Research Corporation, Parker, Colorado.

PRODUCT: ProCide NS Reusable Activated Dialdehyde Sterilizing and Disinfecting Solution in 2.5-gallon, 1-gallon and 1-quart units, a re-usable activated dialdehyde sterilizing and disinfecting solution. Recall #Z-283-0.

REASON: Failure of the product to achieve sterilization or high level disinfection may result in patients being exposed to the risk of infection.

CLASS II

MANUFACTURER: Electric Mobility Corporation, Sewell, New Jersey.

PRODUCT: Rascal and Chauffeur Heavy Duty Scooters: a) Rascal and Chauffeur Heavy Duty 3-Wheel Scooters (Models 205, 235, and 245); b) Rascal and Chauffeur Heavy Duty Indoor 4-Wheel Scooters (Models 255 and 275(; c( Rascal and Chauffeur Heavy Duty Outdoor 4-Wheel Scooters (Models 215, 305, and 315). Recall #Z-529/531-0.

REASON: The drive train gears fail (sheer) allowing the scooters to coast (free-wheel) without control for stopping.

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

PRODUCT: Pacesetter Trilogy Pulse Generator, indicated for the treatment of bradycardia: a) Trilogy (tm) SR 2250L Pulse Generator; b) Trilogy (r) SR+ 2260L Pulse Generator; c) Trilogy (r) SR+ 2265L Pulse Generator; d) Trilogy (tm) DC 2308L Pulse Generator; e) Trilogy (r) DC+ 2318L Pulse Generator; f) Trilogy (tm) DR 2350L Pulse Generator; g) Trilogy (tm) DR+ 2360L Pulse Generator; h) Trilogy (tm) DR+ 2365L Pulse Generator. Recall #Z-536/543-0.

REASON: The devices may exhibit premature battery depletion caused by a current leakage path that could be created during the laser welding process to attach the battery to the device hybrid.

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

PRODUCT: Pacesetter Affinity Dual Chamber Pulse Generators, also known as Cardiac pacemaker: a) Model No. 5130L; b) Model No. 5130R; c) Model No. 5230R; d) Model No. 5330R; e) Model No. 5330L. Recall #Z-544/548-0.

REASON: Decreased reliability has been observed in a limited, very specific, and well-defined group of Affinity pulse generators. Testing has revealed that conductive material used to secure a resistor to the hybrid circuitry may not provide continuous and proper electrical connection to the underlying circuitry. This resistor is used to measure the battery operating current of the pulse generator and is reported to the clinician through the programmer. The battery itself is not affected.

MANUFACTURER: McKinley Medical LLLP, Wheat Ridge, Colorado.

PRODUCT: Outbound Disposable Syringe Infuser and Kits, indiated for intravenous, intra-arterial and subscutaneous delivery of antibiotics, analgesics, or chemotherapeutic agents and other medication or fluids requiring continuous delivery at controlled infusion rates: a) Outbound Disposable Syringe Infuser, Sterile, Catalog No. OB1N00; b) Outbound Surgical Application Continuous Postoperative Pain Control System, Catalog No. 500-120; c) Stryker Pain Pump Disposable Syringe Infuser Surgical Application, Catalog No. 500-110. Recall #Z-549/551-0.

REASON: The pumps would not infuse, prime, or experienced backflow.

MANUFACTURER: Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan.

PRODUCT: Sarns 8K Safety Monitor and 9K Perfusion System, indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures: a) 8000 Perfusion System Safety Monitor, Part No. 98-0702-06606; b) Reconditioned 8K Safety Monitor, Part No. 78-8067-7278-2; c) Trial 8K Safety Monitor, Part No. 78-8067-6878-0; d) Loaner 8K Safety Monitor, Part No. 78-8067-6053-0; e) 9000 Perfusion System 110V, Part No. 98-0702-0270-4; f) 9000 Perfusion System 220V, Part No. 98-0702-0269-6; g) 9000 Perfusion System 100V, Part No. 98-0702-0268-8; h) Reconditioned 9K Perfusion System, Part No. 78-8066-6922-8; I) Trial 9K Perfusion System, Part No. 78-8066-8934-1. Recall #Z-552/560-0.

REASON: The level sensor system malfunctions. The malfunctions have been related to false alarms when there was an adequate fluid level in the reservoir and failure to alarm when the blood level fell below the position of the sensor. 

MANUFACTURER: Avenida Reforma S/N, Local A-3, Tijuana B.C., Mexico.

PRODUCT: Puritan-Bennett Reusable Coupling Temperature Probe, component of the Reusable Volume Ventilator Circuits: a) Reusable Coupling Temperature Probe (Coupler), Catalog No. 4-007897-00; b) Patient Tubing Circuit with Nebulizer, Catalog No. 4-018062-00; c) Simplified Circuit with Vial, Catalog No. 4-018744-00; d) Simplified Circuit without Collector Vial and Adapter, Catalog No. 4-020740-00; e) Simplified Circuit with Traps, Catalog No. 4-015254-00; f) Simplified Circuit with Nebulizer, Catalog No. 4-018052-00; g) Simplified Patient Circuit, Catalog No. 4-018011-00; h) Patient Tubing Circuit - Conventional, Catalog No. 4-019348-00; i) Simplified Patient Circuit, Catalog No. 4-007170-00; ii) Simplified Circuit w/o Vial, Catalog No. 4-018743-00. Recall #Z-561/569-0.

REASON: The flashing in the area of the temperature probe port was not removed.

MANUFACTURER: Thomas Medical Products, Inc., Malvern, Pennsylvania.

PRODUCT: Percutaneous Catheter Introducer Kits containing recalled Clinipad products.

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

MANUFACTURER: Trinity Laboratories, Inc., Salisbury, Maryland.

PRODUCT: Trinity IV Start Kits containing recalled Clinipad Products. Recall #Z-574-0.

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

CLASS III

UPDATES

ALYCON Sample Syringe, 50uL, List #05D49-02, recalled by Abbott Laboratories, Inc., Diagnostics Division, Irving, Texas, which appeared in the April 12, 2000 Enforcement Report should read Recall #Z-534-0.

Roche Reagent for AST, Catalog #42381, recalled by Roche Diagnostics Corp., Indianapolis, Indiana, which appeared in the April 12, 2000 Enforcement Report should read Recall #Z-535-0.

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

CLASS II

MANUFACTURER: Philips Medical Systems, Shelton, Connecticut.

PRODUCT: Tomoscan SR4000, for use in CT radiology. Recall #Z-423-0

REASON: Units are defective under 21 CFR 1003.2 in that the defect occurs when the image is reversed in the unit's data bank. This defect then causes the image to be reversed left to right upon retrieval.

MANUFACTURER: Analogic Corporation, Peabody, Massachusetts.

PRODUCT: Tomoscan M/EG CT Scanner with phase I-Table Controllers and Phase-II Table Controllers, for use in CT radiology. Recall #Z-424/425-0.

REASON: Units are defective under 21 CFR 1003.2 in that they do not interrupt the exposure when the tabletop movement stops during a volume scan mode. This can result in the patient receiving excess exposure at a particular scan plane.

MANUFACTURER: ENDO Surgical Concepts, Inc., Greenwich, Connecticut.

PRODUCT: ENDO Cannulated Bone or Interference Screw, 7.0 mm x 20 mm. Recall #Z-471-0.

REASON: Device may not be sterile.

MANUFACTURER: Institut Straumann AC, Waldenburg, Switzerland.

PRODUCT: ITI 0.4.8mm Esthetic Plus Solid Screw implant ITI Dental Implants are intended for surgical placement in the maxillary and/or manibular arches to provide support for crowns, bridges, or overdentures in endentulous or partially endentulous patients. Recall #Z-472-0.

REASON: Mislabeled - Package incorrectly states diameter as 4.1mm vs 4.8mm diameter.

MANUFACTURER: Medi-Physics, Inc., doing business as Nycomed Amersham Imaging, Arlington Heights, Illinois.

PRODUCT: I-125 Seeds, therapeutic for interstitial brachytherapy, Model 6711. Recall #Z-473-0.

REASON: Seeds have a higher radioactivity than stated on the label.

MANUFACTURER: Biocontrol Technology, Inc., Indiana, Pennsylvania.

PRODUCT: Theraport Vascular Access System, Model 1001, 1002, 1601, 1602. Recall #Z-474/477-0.

REASON: Possible leakage of the portal assembly due to cracks in the outlet tube-to-port weld.

MANUFACTURER: Cryolife, Inc., Kennesaw, Gergia.

PRODUCT: Allograft Heart Valve, Model AVOO. Recall #Z478-0.

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

CLASS III

MANUFACTURER: Acumed, Inc., Beaverton, Oregon.

PRODUCT: Sterile 3.5mm x 27.5mm Cortical Screw. Recall #Z-479-0.

REASON: Package labeling on the sterile version of this part incorrectly states that the cortical screw belongs to the Polarus Humeral Fixation System family. This device is intended to be used with IM Rod System.

MANUFACTURER: Abbott Laboratories, Inc., Irving, Texas. Vendor, Media Magnetics, Richardson, Texas (the firm that duplicated the disks).

PRODUCT: Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0.

REASON: The disks are improperly duplicated and contain software that will install system International (SI) units, rather than conventional units as labeled.

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

PRODUCT: Aeroset Analyzer, used for in-vitro diagnostic tests. Recall #Z-489-0.

REASON: Under certain washing conditions, software error causes erratic urine creatinine results. 
 

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