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FDA Recalls

Attention all mdi Clients:

FDA Recalls by week, May - July 1999

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 21, 1999:

CLASS II

MANUFACTURER: Synthes (USA), West Chester, Pennsylvania.

PRODUCT: Connecting screw and compression screw for titanium solid humeral nails, Part Numbers: 358.54 and 358.61. Recall #Z-1066/1067-9

REASON: Product drawing contained an interference issue which created a potential for the connecting screw not to fit into or bind within the insertion handle.

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

PRODUCT: DePuy Self-Centering Hip Cups: a) Size 22.225 mm, Product No. 1035-44-000; b) Size 28 mm, Product No. 1037-45-000. Recall #Z-1082/1083-9.

REASON: Labeling mix-up - A 28 mm cup was found in a carton labeled as a 22.225 mm cup, and a 22.225 mm cup in a carton labeled as a 28 mm cup.

MANUFACTURER: Bivona Medical Tech., Division of UroQuest Med. Corporation, Gary, Indiana.

PRODUCT: Bivona Fome-Cuf Pediatric Tracheostomy Tube with Stomaseal, Catalog No. 85PO45. Recall #Z-1084-9.

REASON: The tube's outer shaft diameter printed on the neckflange of the tube differed from that on the label.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 14, 1999:

CLASS II

MANUFACTURER: Boston Scientific Corporation, San Jose, California

PRODUCT: CVIS Insight Imaging Catheter for intraluminal coronary interventional procedures; 2.6French/30 MHz and 2.6French/40 MHz, Model C3020 and C3005, indicated for ultrasound examination of the coronary intravascular pathology only. Intravascular ultrasound is indicated in-patients who are candidates for transluminal coronary interventional procedures. Recall #Z-1051/1052-9

REASON: The product may separate from the proximal segment.

MANUFACTURER: Midmark Corporation, Versailles, Ohio.

PRODUCT: Midmark 73018 Attachment Accessories for the Midmark Magnum General Table, hydraulic, sold as kits and are designed for use in the support of patients during orthopedic surgery procedures. Recall #Z-1053-9.

REASON: Defects of table accessories cause unintended motion during orthopedic surgery.

MANUFACTURER: Henley Healthcare, Inc., Sugarland, Texas.

PRODUCT: Henley Healthcare Fluidotherapy Unit, air-fluidized beds employing dry heat that is intended to treat local pain, range of motion and blood flow insufficiency in the body extremities: a) Henley Healthcare Fluidotherapy, Model 110D; b) Henley Healthcare Fluidotherapy, Model 110DE, Recall #Z-1054/1055-9

REASON: Excessively long metal bolts securing metal legs to the wooden base of the device protruded too far into the housing, contacting the electrical connection to the heater after collapsing a metal heater schroud, causing 13 amps of electrical current to be delivered to the metal legs.

MANUFACTURER: Digisonics, Inc., Houston, Texas

PRODUCT: Doctors Review System, OBLink software releases prior to 9.0. Recall #Z-1056-9.

REASON: Y2K software error may produce an incorrect estimated delivery date (EDD)

MANUFACTURER: Becton Dickinson Microbiology Systems, Cockeysville, Marland

PRODUCT: QTEST (r) STREP, an IVD kit for P.O.C. testing to detect Group A Streptococcus, using a sample throat swab, Catalog 494776 - 40 tests/kit; 494780 - 80 tests/kit. Recall #Z-1058-9

REASON: The Vol-pak pouch sealer failed to provide an adequate seal, and the Quali-pak leak tester failed to detect the inadequate seal.

MANUFACTURER: Becton Dickinson Microbiology Systems, Cockeysville, Maryland.

PRODUCT: DIRECTIGEN 1-2-3 GROUP A STREP TEST, DEVICE LISTING 702228, an IVD kit used by hospitals for detection of Group A streptococcus using a sample of throat swabs or bacterial colonies. Recall #Z-1059-9.

REASON: The VolPak pouch sealer failed to provide an adequate seal, and the QualiPak leak tester failed to detect the inadequate seal. An inadequate seal may lead to false negative results.

MANUFACTURER: Quest Medical, Inc., (QMI), an Atrion Company, Allen, Texas.

PRODUCT: Quest Myocardial Protection System (MPS), a sterile, single-use, prescription device: a) Model No. 5001101; b) Model No. 5001101 NE; c) Model No. 5001102. Recall #Z-1061/1063-9

REASON: The delivery sets may develop a leak in the main pump cassette during use.

MANUFACTURER: AB Sangtec Medical, Bromma, Sweden.

PRODUCT: Ampilcor HBV Monitor(tm) Kit, an IVD test that utilizes PCR nucleic acid amplification and Dna hybridization for the detection and quantitative measurement for Hepatitis B viral DNA in human serum or plasma: a) Catalog No. 87521/0757160 (Domestic), Amplicor HBV Monitor(tm) Test "For Research Use Only"; b) Catalog No. 83271/0757152 (International), Amplicor HBV Monitor (tm) Test "For in Vitro Diagnostic Use". Recall #Z-1064/1065-9

REASON: The IS values for the standards are low which results in HBV/IS OD ratios which are high and outside of the kit-specified acceptance criteria causing invalid runs.

CLASS III

MANUFACTURER: Steris Corporation, Mentor, Ohio.

PRODUCT: Steris Process Biological Indicator; the kit includes 20 biological indicators (B.stearothermophilus), 20 vials filled with growth medium, and a Certificate of Performance and Instruction Card, to be used in conjunction with STERIS Chemical Monitoring Strips. The product is shipped frozen.

REASON: Product failed stability testing at three (3) months. The spore counts dropped below labeled specification.

MANUFACTURER: Eastman Kodak Company, Health Imaging Division, Rochester, New York.

PRODUCT: Kodak Digital Science Medical Film EIR-11 Laser Imaging Film intended for secondary imaging of radiographs, packed 150 sheets per box. Recall #Z-1057-9

REASON: The film was exposed to light during the rewind process, and has an elevated background fog. The normal level of fog has a Dmin of 0.30.

MANUFACTURER: Abbott Laboratories, Abbott Park, Illinois.

PRODUCT: ARCHITECT Estradiol Reagent Kit, list 6C22-20 - 4 x 100 tests and list 6C22-25 - 1 x 100 tests; and in-vitro diagnostic Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of estradiol in human serum and plasma. Recall #Z-1060-9.

REASON: The Architect Estradiol Reagents may show under-recovery of estradiol with undiluted patient specimens.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 7, 1999:

CLASS II

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

PRODUCT: IMED Gemini PC-2, 220 Volt Volumetric Infusion Pump/Controller with a titration feature, used to provide automatic infusion of intravascular drugs, fluids, blood and blood components in a hospital environment. Recall #Z-084-9

REASON: The device is subject to lockup, resulting in an interruption of fluid delivery caused by an incorrect installation of a Watchdog FET.

MANUFACTURER: Ethox Corporation, Buffalo, New York.

PRODUCT: Ethox brand Weighted Feeding Tube, "Easy Glide", Catalog #9210, Nasogastric/nasointestinal feeding tube with stylet, sterile, disposable. Recall #Z-1008-9.

REASON: The tungsten weighted tip may separate from the tube during use.

MANUFACTURER: BLD Medical Products, Dallas, Texas.

PRODUCT: 40 cm H20 Pop-off Elbow, (sold separetely and component of Assist Circuit and Resuscitators): a) Stand alone 40 cm H20 Pop-off elbow, Product No. BLD-1024; b) BLD Pulmonary Assist Circuit (PAC) containing the 40cm H20 Pop-off elbow, Product No. B:D-83124; c) PULMANEX Pulmonary Manual Resuscitators, containing the 40cm H20 Pop-off elbow, Product Nos. BLD-9140, BLD-9142, BLD-9146, BLD-9147, BLD-9187m BLD-9192, BLD-9198, BLD-9244, BLD-9245, BLD-9246, BLD-9249, BLD-9257, BLD-9262, BLD-9291, BLD-9294, BLD-9348, BLD-9390, BLD-9392, BLD-9394, BLD-9395, BLD-9396, BLD-9397, BLD-9398, BLD-9410. Recall #Z-1028/1030-9.

REASON: The Pop-off elbow, used to limit valve to maximum pressure, may contain excess plastic material (flash) that could break off and migrate into the patient airway during treatment.

MANUFACTURER: Roche Molecular Systems, Inc., Somerville, New Jersey.

PRODUCT: Amplicor Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Amplification Kit, Catalog No. 83319/07 59902 (Art. 07 59902), sold as an export only product. Recall #Z-1031-9.

REASON: The CT (+) Control and the CT Internal Control may give low absorbance readings which may give false negative results.

MANUFACTURER: Synthes (USA), Monument, Colorado,

PRODUCT: Synthes Elastic Intramedullary Nail (Ein) System, Part # 475.935S. Recall #Z-1032-9.

REASON: Product was packaged with insert GP0735 which is an insert for One Step Lag Screw. The product should have been packaged with insert GP0935.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Laminectomy Punch 40 Degree up-biting, Part #U44-255-30. Recall # Z-1036-9.

REASON: Mislabeled - Label indicates punch has a 3 mm bite. The punch in the package (U44-255-20) has a 2 mm bite.

MANUFACTURER: Hitachi Ltd., Instrument Division, Ibari-Ken, Japan.

PRODUCT: Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistry analyzer system. Recall #Z-1040-9.

REASON: The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1043-9.

REASON: Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft (Heart Valve), Model PV00. Recall #Z-1044-9.

REASON: Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft (Heart Valve), Model PV00 Recall #Z-1-45-9.

REASON: Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft (Heart Valve), Model PV00 Recall #Z-1046-9.

REASON: During a recent review of donor 36936 records, discodant HbcAb results were discovered in the donor's serological testing profile. Current Federal regulations for human tissues mandate that any discordant serological testing results for viral markers be reported as "repeatedly reactive". This donor's serological test for HbcAb was incorrectly report as "nonreactive".

CLASS III

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: 4.5 mm Shaft Screw - 30 mm, Part #214.230. Recall #Z-1033-9.

REASON: Seven screws in the lot were mislabeled with a label from part number 209.870 lot #A3LR166 (7.3 mm Cannulated Screw - 70 mm).

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Flexible Shaft Connector for use with Jacobs Chuck, Part # 351.16J. Recall #Z-1034-9.

REASON: Flexible shaft connector for hand reaming (351.16) was packaged and labeled as a Flexible Shaft Connector for use with Jacobs Chuck (351.16J). The instructions to convert the part were not complete.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: TI-6AL-7NB URTN, Part number 476.36S, a tibial nail. Recall #Z-1035-9.

REASON: Mislabeled - The outside package indicates the product is a Ti Solid Tibial Nail 10 mm x 360 mm (476.36S). The contents of the inner package are a Ti Cannulated Tibial Nail 13 mm x 420 mm (458.342S) of Lot #A3LH315.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Synthes Anatomical Locking Plate System, Part #292.699.111. Recall #Z-1037-9.

REASON: The device is 275 mm long instead of 280 mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 30, 1999:

CLASS II

MANUFACTURER: Synthes (USA), Monument, Colorado

PRODUCT: Synthes Sterile Drill Bits, Part #356.982. Recall #Z-985-9

REASON: Package insert was not placed in packaging when the product was sent out.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Synthes Mandibular Modular Fixation System, Part #449.236. Recall #Z-986-9

REASON: Package insert was not placed in packaging when the product was sent out.

MANUFACTURER: Synthes (USA), West Chester, Pennsylvania

PRODUCT: Synthes Spine Anterior Thoracolumbar Rod Clamp. Recall #Z-987-9.

REASON: The connector is not compatible with VentroFix System. The distance at which the parallel connector maintains the rods is less than that which clamps provide.

MANUFACTURER: Gibbons Surgical Corporation, Virginia Beach, Virginia

PRODUCT: SK (sterile kits) kits, consisting of replacement seals and valves for cannulas: Model SK1, SK2, SK3, SK4. Recall #Z-990/993-9

REASON: Devices were dosed at a different level than that documented in validation study.

MANUFACTURER: Smith & Nephew Homecraft, Ltd., Farnham, Surrey, UK.

PRODUCT: Liftmaster Patient Hoist, Models 160 and 190 (Catalog numbers AA8940/AA8945). Recall #Z-1003/1004-9.

REASON: Devices were dosed at a different level than that documented in validation study.

MANUFACTURER: C.R. Bard Puerto Rico, Las Piedras, Puerto Rico. PRODUCT: Bard Cardiopulmonary Extrtacorporeal Cannulae, intended for use in cardiovascular surgery to cannulate vessels or perfuse arteries: Z-1012-9 - Models: 007300, 007301, 007302, 007303. Overall Length: 17.5cm, 14-20F, 3/8 inch connector. Z-1013-9 - Models: 007350, 007351. Overall Length: 17.5cm, 10&12F, 1/4 inch connector. Z-1014-9 - Models: 007267, 007268, 007269, 007270, 007271. Overall Length: 41.5cm, 16-24F, 3/8 inch connector. Z-1015-9 - Models: 007274, 007275, 007276, 007277, 007278, 007279, 007280, 007281, 007282. Overall Length: 41.5cm, 10-26F, 1/4 inch Connector. Z-1016-9- Model: 007720, 007721, 007722, 007723. Overall Length: 27.5cm, 10-16F, 1/4 inch connector. Z-1018-9 - Model: GA Special Order product attributes, such as length, French size, etc. GA Item #'s: 007274-007282, 007773, 007720-007723 Special order - GAXXXXXX (X+ ANY NUMBER 0-9)

REASON: Sterile barrier may be compromised.

MANUFACTURER: Kelsar, S.A., Tijuana, Mexico.

PRODUCT: Argyle DeLee Suction Catheter w/Mucous Trap, intended to aspirate liquids or semisolids from a patient's upper airway. Recall #Z-1019-9.

REASON: Product may be non-sterile.

MANUFACTURER: Power Technology, Inc., Mabelvale, Arkansas

PRODUCT: Laser Systems and Communication lasers: a) Model No. DY Laser Systems; b) Model No. DYH Laser Systems; c) Model No. LCT Class IIIb Communication Laser. Recall #Z-1022/1024-9

REASON: The model DY and DYH laser systems were introduced into commerce uncertified and did not comply with the performance standard (Section 538 of the Federal Food, Drug, and Cosmetic Act and 21 CFR 1010.2). The Class IIIb LCT communication lasers failed to have a remote interlock connector, an adequate beam attenuator, and the correct text on the warning logotype label (CFR 21 1040.10(f) (3), 21 CFR 1040.10(f) (6), (21 CFR 1040.10 (g) (2) (iii).

MANUFACTURER: Alphatec Manufacturing Inc., Palm Desert, California.

PRODUCT: MHS Manual Hexdriver, Part #10150, used to screw in or out the appropriate 10010-XX bone screws that secure the Alphatec modular barrel plate extensions against the proximal femur. Recall #Z-1026-9

REASON: The hexdriver shaft was not heat treated as indicated in the specifications.

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

PRODUCT: IVACMedSystem III Infusion System, a three-channel microprocessor based fluid delivery device for use to control and monitor infusion via intravenous, intra-arterial or subcutaneous routes: a) Model 2860: three-channel, general purpose, infusion pump, 110V; b) Model 2863: three-channel, general purpose, infusion pump, 110V; c) Model 2866: three-channel, general purpose, infusion pump, 220V (international), and a power supply board kit for use as a replacement power supply board for the Medsystem III pump. Recall #Z-1027-9

REASON: Capacitors in the power supply board are failing causing the pumps to shut down/stop infusing without an alarm notifying the user.

CLASS III

MANUFACTURER: Synthes (USA), Monument, Colorado

PRODUCT: 1.5 mm TI Cortex Screw Self Tapping 8 mm and 12 mm, Part numbers 400.808.96 and 400.812.96. Recall #Z-988/989-9.

REASON: Product was mislabeled. The label placed on the device was blue instead of mauve. A blue label is for 2.0 mm diameter screws. The text on the label was correct.

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

PRODUCT: Ortho Chlamydia Antigen ELISA Test, diagnostic test kits. Recall #Z-999-9.

REASON: OPD Substrate Tablets have deteriorated resulting in inaccurate test results.

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

PRODUCT: ORTHO HSV Antigen ELISA Test, Modification, diagnostic test kits for the detection of herpes simplex virus. Recall #Z-1000-9.

REASON: The OPD Substrate Tablets have deteriorated resulting in inaccurate test results.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Synthes (USA) Midfacial System Part Numbers 446.516 and 447.515. Recall #Z-1005/1006-9.

REASON: Product was mislabeled. The plates were anodized gold and should have been green/gray.

MANUFACTURER: Data Medical Associates, Inc. Arlington, Texas

PRODUCT: One Shots HDL Precipitating Reagent, for in-vitro diagnostic use in 0.5 ml tubes, packaged in a blue plastic pail containing 250 tubes. Recall # Z-1011-9

REASON: The reagent tubes contain less reagent volume than indicated on the label.

MANUFACTURER: Smith & Nephew, Inc., Mansfield, Massachusetts.

PRODUCT: Acufex Tibial anchor Screw & Spiked Washer, indicated for use in fixation of soft tissue in orthopedic procedures. Recall #Z-1011-9.

REASON: The head of the screw may break during insertion.

MANUFACTURER: Abbott Laboratories, Abbott Park, Illinois.

PRODUCT: Imx Estradiol Reagent Pack, List #2215-22, 100 tests, an in-vitro diagnostic microparticle enzyme immunoassay for the quantitative measurement of estradiol in human serum and plasma on the Imx Analyzer. Recall #Z-1021-9.

REASON: Lots may show underrecovery of estradiol with undiluted patient specimens.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  June 23, 1999

CLASS II

MANUFACTURER:  Abiomed, Inc., Danvers, Massachusetts

 PRODUCT:BVS 5000i Bi-Ventricular Support System, intended for use as a mechanical circulatory support system.  Recall #Z-944-9. 

REASON:Solenoid valves do not provide adequate flow to the blood pump.

MANUFACTURER:  Nissho Nipro Corporation, Sena, Ayuhaya, Thailand.

PRODUCT: Seraflo Q-Set Hemodialysis Tubing Set (common name is “Q-set Bloodlines” varies catalog numbers.   Recall #Z-967/979-9.

REASON:  The dialysis machines which utilize the Seraflo bloodlines may become contaminated with blood due to blood backing up in the bloodlines.

MANUFACTURER:  Gibbons Surgical Corporation, Virginia Beach, Virginia.

PRODUCT: Shielded Trocar (obturator), Model GT012, GT011, GT05, GT-05-7, GSNT11.  Recall #Z-994/998-9.

REASON:  Gamma sterilization was not validated.  Devices were dosed at a different level than that provided for in validation study.

MANUFACTURER: Linvatec Corporation, Largo, Florida.

PRODUCT:   Apex Universal Irrigation Console, pumps intended to provide necessary pressure ranges during arthroscopy from 20 to 150 mmHg.  They also provide flow rates of up to 2000ml/min for proper and safe joint distension and visualization:

a)       Model C7100

b)       Model C7100A.

Recall #Z-1001/1002-9. 

REASON: Pump may only operate intermittently.

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

PRODUCT:   IMMUNOCARD (TM) C. DIFFICILE, diagnostic test kit used for the detection of C. difficile Common Antigent.  Recall #Z-1007-9.

REASON:   Negative color reactions may result in invalid or false negative test results

MANUFACTURER:    Cook Incorporated, Bloomington, Indiana.

PRODUCT:  Patil Emergency Cricothyrotomy Catheters:

          a)       Cook Citical Care Brand Patil EmergencyCriicothyrotomy Catheter Set with 6 French Airway Catheter, Reorder No. C-DTJV-6.0-6.0-PATIL.
          b)       Cook Critical Care Brand Patil EmergencyCricothyrotomy Catheter Set with 9 French Airway Catheter, Reorder No. C-DTJV-9.0-6.0-PATIL. Recall #Z-1009/1010-9.

REASON:   The 6 cc syringe will not connect to the cricothyrotomy catheter, thus not allowing aspiration to verify correct final placement of the catheter within the trachea as per the instructions for use.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 16, 1999

CLASS I

MANUFACTURER: Total Resources International, Inc., Walnut, California.

PRODUCT: Get Smart Be Prepared, 207 piece Emergency First Aid Kit. Recall #Z-954-9.

REASON: The Providone Iodine pads in the kits are contaminated with microorganisms such as Pseudomonas putida, Salmonella spp., Poly D, and Aeromonas sorbia.

CLASS II

MANUFACTURER: Fischer Imaging Corporation, Denver, Colorado.

PRODUCT: IiRAD DR1000C Digital Chest System, general purpose x-ray device Recall #Z-949-9.

REASON: The units are defective under 21 CFR 1003.2 in that they do not assure certification to field sizing specifications are met because the system intermittently opens wide open in the vertical direction when the exposure button is depressed. This can result in the patient receiving excess exposure where no useful diagnostic imaging can occur.

MANUFACTURER: CryoLife, Inc., Kennewaw, Georgia.

PRODUCT: CryoValve Allograft (heart valve), Model PV00. Recall #Z-980-9.

REASON: The donor's final autopsy report, which included a histological exam of the donor's brain, revealed evidence of viral encephalitis.

MANUFACTURER: CryoLife, Inc., Kennewaw, Georgia.

PRODUCT: CryoValve Allograft (heart valve), Model PV00. Recall #Z-981-9.

REASON: The donor's final autopsy report revealed Undiagnosed Sarcoma (Fibrosarcoma) of the right leg.

MANUFACTURER: CryoLife, Inc., Kennewaw, Georgia.

PRODUCT: CryoValve Allograft (heart valve): a) Model No. AV40, Serial No. 6285082 b) Model No. AV05. Serial No. 6314988 Recall #Z-982/983-9.

REASON: The donors do not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

UPDATE Model CVX CVX-300 Excimer Laser, Recall # Z-934-9, which appeared in the June 2, 1999 Enforcement Report should read: CODE Serial numbers: 1468 thru 1502, 79600, 79601, 79602, 79603, 79605, 79606, 79610 thru 79631, 79805 , 79806, 79807, 79808. DISTRIBUTION: Nationwide, Argentina, Canada, Europe. Quantity: 67 units were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

UPDATE Hemoglobin Reagent, Recall #Z-947-9 which appeared in the June 8, 1999 Enforcement Report is a Class III recall.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 9, 1999

CLASS II

MANUFACTURER: EG & G Wallace, Inc., Norton, Ohio

PRODUCT: Hemoglobin Reagent. Recall #Z-947-9.

REASON: Product is packaged with an insert sheet which incorrectly identifies the control as Hb A/S in the heading, instead of the correct control identification of Hb A/F.

MANUFACTURER: Canon, Inc., Tokyo, Japan.

PRODUCT: Acoma X1000 Hydraulic Stand, Item #SSB-T0959-6, part of the Trans X-1000 Fully Automatic Chest X-ray system, intended for use in general radiographic applications. The Trans X-1000 is a fully automatic chest film changer. It provides a direct film transport mechanism between the film supply magazine and the film processor, a fully automatic chest film changer. Recall #Z-942-9.

REASON: The arm support mechanism (handle) can break.

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

PRODUCT: CMV IgM ELISA Test System, an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to cytomegalovirus. Recall #Z-943-9.

REASON: The product may produce false positive test results.

MANUFACTURER: Power Technology, Inc., Mabelvale, Arkansas.

PRODUCT: Lasers and Laser Pointers: a) Model No. LCM-T Lasers b) Model No. LP-1M Laser Pointers c) Model No. LP-2M Laser Pointers d) Model No. GP-2 (Pulsed) Laser Pointers Recall #Z-950/953-9.

REASON: The LCM-T lasers were introduced into commerce uncertified and did not comply with the performance standard (Section 538 of the Federal Food and Drug and Cosmetic Act and 21 CFR 1010.2). The LP-1M and the GP-2 (pulsed) laser pointers exceeded the Class IIIa and Class II single pulse energy limits of the laser standard (21 CFRE 1040.10 (c) (1). The LP-2M laser pointer failed to have a remote interlock connector, an adequate beam attenuator and the correct text on the warning logotype label (21 CFR 1040.10 (g) (2) (iii).

CLASS III

MANUFACTURER: EMPI, Inc., St. Paul, Minesota.

PRODUCT: Minnova Pelvic Floor Stimulation System; and InnoSense Pelvic Floor Stimulation and Electromyography System. Both systems use mild electrical stimulation to help control urinary incontinence. Recall #Z-865/866-9.

REASON: An oversized dimension of an electrical pin connector in a socket in each device will result in an incorrect electrical connection between the patient electrode and the device.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 2, 1999

CLASS II

MANUFACTURER: Boston Scientific Corporation, Ireland, Ltd., Galway, Ireland.

PRODUCT: Scimed Ranger 20 mm Percutaneous Coronary angioplasty (PTCA) Dilatation Balloon Catheter. Recall #Z-923-9.

REASON: The wrong/unvalidated sterilization process was used for the two recalled lots.

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, Florida.

PRODUCT: Innovative Implants and Cover Screws. Recall #Z-926-9.

REASON: Product was mislabeled as 6.0mm when it was actually 5.0mm.

MANUFACTURER: Carl Zeiss, Inc., Thornwood, New York.

PRODUCT: Model Visulas Laser System, used in ophthalmology: a) Model No. 532 b) Model No. 532 Combi c) Model No. 690s d) Model No. 732S e) Model Yag II Plus Recall #Z-929/933-9.

REASON: Device failed to comply with 21 CFR 1040.11 (a) (2) in that the operator's manual lacked calibration procedures. 

MANUFACTURER: Spectranetics Corporation, Colorado Springs, Colorado.

PRODUCT: Model CVX-300 Excimer Laser, used in cardiology. Recall #Z-934-9.

REASON: The device failed to comply with 21 CFR 1040.10 (f) (1) in that the protective housing had a narrow gap allowing direct line-of-sight access to the Class IV beam. 

MANUFACTURER: Palomar Medical Products, Inc., Lexington, Massachusetts.

PRODUCT: Model E2000 Ruby Laser System. Recall #Z-935-9.

REASON: The device failed to comply with 21 CFR 1040.11 (a) (2) in that the operator's manual lacked calibration procedures.

MANUFACTURER: Steris Corporation, Erie Pennsylvania.

PRODUCT: Eagle 3000 Floorloader Steam Sterilizer. Recall #Z-936-9.

REASON: There is an error in the control system software, which causes the chamber temperatures to exceed the upper limit.

MANUFACTURER: Southmedic, Inc., Ontario, Canada (assembler/packager).

PRODUCT: Tissue Suture Anchors, used to reattach soft tissue to bone during surgery: a) Part No. PAE5K - OBL RC5 R.0 mm Suture Anchor b) Part No. PAS2K - PeBA S 2.8 mm Suture Anchor Recall #Z-937/938-9.

REASON: The sterility of the lots cannot be assured due to a packaging defect that occurred during the heat sealing process.

MANUFACTURER: Invacare Corporation, Sanford, Florida.

PRODUCT: Portable Oxygen Generator: a) Model 5Lxo2 b) Model 6LX02 Recall #Z-939/940-9.

REASON: Oxygen concentrators had a high incidence of reported circuit board failures.  

MANUFACTURER: Invacare Corporation, Elyria, Ohio.

PRODUCT: Patient Scale, Model RSC600. Recall #Z-941-9.

REASON: Screw, which secures scale, may become disengaged, causing patient/occupant to fall from scale.

CLASS III

MANUFACTURER: DiChem Concentrates, Inc., Lewisberry, Pennsylvania.

PRODUCT: a) Cobe Renalyte Rx Acid Concentrate for Bicarbonate Dialysate, 2-K and 2.5 Ca, Product Number 012-116-004. b) Cobe Renalyte Rx Acid Concentrate for Bicarbonate Dialysate, 2-K, product number 012-111-004. Recall #Z-927/928-9.

REASON: Some product was mislabeled as product code 012-111-004 bicarbonate dialysate.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 28, 1999

CLASS II

MANUFACTURER: Gesco International, Inc., San Antonio, Texas.

PRODUCT: Poly Per-Q-Cath Single Lumen Catheters. Varies Catalog Numbers. Recall #Z-806-/816-9.

REASON: The catheters may leak near the hub in the area of skin insertion.

MANUFACTURER: Hamilton Company, Reno, Nevada.

PRODUCT: Hamilton Disposable Precision Tips, a Microlab AT Series Instrument, a pipette used to aspirate and dispense fluid including blood products: a) Model 235300 b) Model 235400 Varies Code Numbers Recall #Z-818-/819-9.

REASON: There is a defect in the molding of the plunger.

MANUFACTURER: Porter Instrument Company, Inc, Hatfield, Pennsylvania.

PRODUCT: MXR-2000 Flowmeter, used to administer an analgesic agent for conscious sedation: a) Model 2050 b) Model 2055. Recall #Z-820-/821-9.

REASON: Mounting screws were defective and found to have brittle fractures after final assembly and testing.

MANUFACTURER: Device Resources Corporations, Lake Bluff, Illinois.

PRODUCT: Jackson Esophageal Dilator 14F, Catalog numbers: 50-7808, 50-7809, 50-7810, 50-7812, 50-7814, 50-7816, 50-7818. Recall #Z-822/828-9.

REASON: Esophageal dilator tips come off the metal shaft.

MANUFACTURER: AMPC, Inc., Lytton, Iowa

PRODUCT: American Protein Corporation Steamed Bone Meal in 50 pound bags American Meat Protein Corp. Steamed Bonemeal, 2,000 pound tote bags. Recall #V-047-9.

REASON: Product contained protein derived from mammalian tissue and according to regulation must bear the statement "Do not feed to cattle or other ruminants" on the label. This regulation is designed to prevent the establishment and amplification of BSE through feed. This statement did not appear on the labeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 19, 1999:

CLASS II

MANUFACTURER: DPC Cirrus, Inc., a subsidiary of Diagnostic Products Corporation, Randolph, New Jersey.

PRODUCT: All IMMULITE 2000 Automated Immunoassay Analyzers with Software Version 1.1, a clinical automated immunoassay analyzer intended for in-vitro diagnostic use for detection of analytates in human specimens. Recall #Z-909-9.

REASON: If the initial counts of the reaction tubes are exactly 10,000 cps, this leads to erroneously low calculated results.

MANUFACTURER: Abbott Laboratories, Irving, Texas.

PRODUCT: All Architect I System Processing Modules with Software Versions 1.0 and 1.01. Recall #Z-910-9.

REASON: The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records.

MANUFACTURER: Medtronic Interventional Vascular, Inc., Danvers, Massachusetts.

PRODUCT: 8F Zuma Guiding Catheter, designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system. Recall #Z-911-9

REASON: Instructions for use are inadequate.

MANUFACTURER: Allegiance Healthcare Corporation, Clearwater, Florida.

PRODUCT: Coaxial Biopsy System composed of an introducer (coaxial needle) and an 18 gauge biopsy needle for specimen sampling, marketed under the Achieve label, Bauer Medical, Inc., packaged 5 systems per box. Recall #Z-914-9

REASON: The introducer needle (19 gauge) is too small in diameter for the 18 gauge biopsy needle to insert through it, preventing specimen sampling.

MANUFACTURER: Althin Medical, Inc., Miami Lakes, Florida

PRODUCT: System 1000 and Tina Single Patient Hemodialysis Delivery System with DPSND and SPSND options that are fitted with a J089700 Arterial Line Clamp. Also there are Spare Part Kits that are under recall because they contain the suspect Arterial Line Clamp, their spare part numbers J08970S and K100DRC. Recall #Z-912/913-9

REASON: Damaged, leaking blood lines.

MANUFACTURER: Invacare Corporation, Sanford, Florida.

PRODUCT: Mobilite Electric Homecare Bed. Recall #Z-915-9

REASON: Old style pull ring may cause serious finger injuries.

MANUFACTURER: Millipore, Cork, Ireland

PRODUCT: Millipore Vented Millex GS Sterilizing Filter Unit (Sterile and Non-Pyrogenic), intended for sterilizing aqueous solutions, such as antibodies and critical care solutions dispensed with a syringe. Recall #Z-918-9.

REASON: Sterile Filter exceeds USP limits for Bacterial Endotoxins.

UPDATE Baxter Healthcare Corporation, (Deerfield, IL) Colleague 3 Volumetric Infusion Pump (Triple Channel) for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications, Recall #Z-872-9 which appeared in the May 12, 1999 Enforcement Report should read: Code: Product Code 2M8153, all serial numbers.

CLASS III

MANUFACTURER: Becton Dickinson Surgical Systems, Sarasota, Florida.

PRODUCT: Visitec Visidrape, sterile disposable surgical drape used primarily for ophthalmic surgery: Catalog Numbers 581087 and 581088. Recall #Z-919/920-9.

REASON: Surgical orientation mark is incorrect.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 12, 1999:

CLASS II

MANUFACTURER: Sims Portex, Inc., Keene, New Hampshire

PRODUCT: 25 G Whitacre Needle Spinal Tray, intended to be used in the administration of a regional or local anesthesia to a patient. The tray contains 5% Lidocaine with 7.5% Dextrose, 2 ml. Recall #Z-817-9

REASON: Product labeled as sterile was not sterilized.

MANUFACTURER: Owens-BiGam Medical Company, Newland, North Carolina

PRODUCT: Hyperinflation Sets and Resuscitator. Recall #Z-831/832-9.

REASON: Damage to the oxygen tubing could cause leaks in the tubing that would result in inconsistent flow rates.

MANUFACTURER: P.A.K Manufacturing, Inc., Melbourne, New Jersey (contract manufacturer).

PRODUCT: Dual Purpose Rocker Instrument, Part # 4009, 6.35" size, non-powered surgical instrument intended to help introduce/seat the spinal brace rods deeper into the adult hooks or variable locking screws to allow easier application of the slider or hex nut. Recall #Z-852-9.

REASON: The device will not allow the proper assembly of a slider into a hook when used in accordance with the product instructions for use.

MANUFACTURER: Millar Instruments, Houston, Texas

PRODUCT: a) 5 Fr Angiographic Catheters Model Nos. SPC-454D, SPC-454E, and SPC-454F; b) 5 Fr Pressure/Volume Catheters; Model Nos. SPC-465A, SPC-550, SSD-795, and SSD-814. Recall #Z-853/854-9.

REASON: A coagulated clot was found within the catheter which were made of nylon instead of polyurethane as specified in the firm's 510(k).

MANUFACTURER: Quinton Instrument Company, Bothell, Washington

PRODUCT: Quinton Q-Cath Hemodynamic Analysis System, a hemodynamic recording system, which acquires, displays, stores and may print out waveform data acquired from a patient undergoing a cardiac catheterization procedure: a)Q-Cath; b)Q-Cath II; c)Q Cath II NT; d) Q-Cath DS; e) Q-Cath Remote Station. Recall # Z-855/859-9.

REASON: Device has potential to display previous patient's blood pressure.

MANUFACTURER: Medtronic Med Rel, Inc., Humacao, Puerto Rico; Medtronic, Switzerland Manufacturing Operations, Tolochenaz, Switzerland.

PRODUCT: GEM Implantable Cardioverter Defibrillator: a) Model No. 7226Cx; b) Model No. 7227. Recall #Z-860/861-9.

REASON: A high current drain in some of the defibrillators causes premature battery depletion.

MANUFACTURER: Burton Medical Products Corporation, Chatsworth, California.

PRODUCT: FlexiMount Ceiling Track Mount System with Trolly, Model #0102180, part of the mounting system designed to connect the Burton Outpatient Plus, Outpatient II, Coolspot and Coolspot lights to the ceiling. Recall #Z-862-9

REASON: The device has the potential to fall because setscrews used to secure the down-tube on the trolley were omitted from the installation pack.

MANUFACTURER: ERBE, Tubingen, Germany

PRODUCT: Pressure Reduction Valve, Part #20132-065, a component of the Argon Plasma Coagulation (APC) Unit. Recall #Z-863-9.

REASON: The valve has the potential to separate from the Argon tank because it does not fit securely in the tank.

MANUFACTURER: Oberlikon Contraves, A.G., Zurich Switzerland

PRODUCT: NC_1 Floor to Ceiling Mount, an accessory to a microscope used for various surgical procedures. Recall #Z-864-9.

REASON: The device has the potential to fall during use.

MANUFACTURER: Vesta, Inc., Franklin, Wisconsin

PRODUCT: Storz Silicone Tire Implant for Retinal Detachment Surgery a) Catalog No. E5381 721 (287 Style); b) Catalog No. E5381 620 (78g Style). Recall #Z-867/868-9

REASON: The package labeling may not correctly identify the size and style of the contents.

MANUFACTURER: Bayer Diagnostic Manufacturing Ltd., Swords, Co Dublin, Ireland.

PRODUCT: Bayer ADVIA 120 Hematology System, a quantitative automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in-vitro-diagnostic use in clinical laboratories: a)ADVIA 120 Hematology System, Catalog No. 453-0024-03; b) ADVIA 120 Hematology System, Catalog No. 453-0024-04.

REASON: The device may give erroneous results because of the valve gasket deterioration in the Baso Channel check valve, and the software designed will not flag significant discrepancies in the results between the two methodologies at extremely low counts.

MANUFACTURER: Ocular Sciences, Inc., South San Francisco, California.

PRODUCT: Ocufilcon D 55 Visibility Tinted Contact Lenses. Recall #Z-871-9.

REASON: Incomplete seal could compromise product sterility.

MANUFACTURER: Baxter Healthcare PTE. Ltd. Singapore

PRODUCT: Colleague 3 Volumetric Infusion Pump (Triple Channel) for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications. Recall #Z-872-9.

REASON: A software communication error occurs predominately when all three channels are in use, causing an alarm condition (533:320:717:000) that will stop the function of all of the channels in use. The pump will alarm appropriately, alerting the user of the failure state.

MANUFACTURER: Nellcor Puritan Bennett de Mexico S.A. de C.V., Tijuana, Mexico.

PRODUCT: DMR2 Disposable Manual Resuscitators: several model numbers. Recall #Z-874/907-9

REASON: The non-rebreathing valve (NRV) housing assembly may crack resulting in the swivel elbow fitting becoming loose and disengaging from the NRV during use.

CLASS III

MANUFACTURER: Hangzhou Jinchen Knitting & Textiles Co., Ltd., Hangzhou, China.

PRODUCT: Medline Gripper Sport and Gripper II Latex Free Operating Room Shoe Covers: a) Catalog No. NON27752; b) Catalog No. NON27758; c) Catalog No. NON27758R; d) Catalog No. NON27759; e) Catalog No. NON27759R; f) Catalog No. NON27852; g) Catalog No. NON27144; h) Catalog No. NON27144XL. Recall #Z-844/851-9.

REASON: The latex free gripper pattern on the shoe covers is made of a water-soluble substance and may smear and may be more prone to slippage if exposed to water.

MANUFACTURER: EMPI, Inc., St. Paul, Minnesota.

PRODUCT: a) Minnova Pelvic Floor Stimulation System; b) InnoSence Pelvic Floor Stimulation and Electromyography System. Both systems use mild electrical stimulation to help control urinary incontinence. Recall #Z-865/866-9

REASON: Electrical short at a pin connector may change the location of the stimulation to an incorrect location.

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

PRODUCT: IMX HCG Calibrators, for in vitro diagnostic use. The IMx hCG Assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative determination of Human Chorionic Gonadotropin (hCG) in human serum and plasma for the early detention of pregnancy. Recall #Z-873-9.

REASON: Decreased F calibrator rates may result in elevated control and patient values.

MANUFACTURER: Biocompatibles Eyecare, Norfolk, Virginia

PRODUCT: Proclear Daily Wear Contact Lens. Recall #Z-908-9.

REASON: Contact lenses optical power was mislabeled on product.

MEDICAL DEVICE SAFETY ALERTS:

PRODUCT TECHSTAR XL AND Prostarr XL Precutaneous Vascular Surgical Device, intended for the precutaneous deployment and tying of sutures for surgical closure of arterial puncture sites resulting from diagnostic and interventional procedure: Models: TXL-431-06; TXLS-432-06; TXL-431-07; PXL-431-08; PXL-431-10. Safety Alert #N-005/009-9. CODE All codes. MANUFACTURER Perclose, Inc., Redwood City, California. ALERTED BY Manufacturer, by safety alert letters of April 28, 1999 describing the labeling concerns and providing additional sticker labeling for placement on the outer packages. DISTRIBUTION Nationwide and international. QUANTITY 23,960 units were distributed. REASON Misinterpretation of sterility labeling on the inner tray by users may result in contamination and inappropriate use of the trays after the outer pouch sterility barrier has been broken.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 5, 1999

CLASS II

MANUFACTURER: Beckman Coulter, Inc., Brea, California.

PRODUCT: All Datalink Management System Software Versions 4.1, 4.2, and 4.3, Part #464800, a data processing module for clinical use. Recall #Z-829-9.

REASON: The devices may allow the test results from an associated clinical instrument to be placed under an incorrect sample ID.

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

PRODUCT: Vitros ECi Immunodiagnostic System, an automated continuous random access immunoassay analyzer, Catalog No. 8633893. Recall #Z-830-9.

REASON: Autodilution pump does not consistently dispense the expected amount of diluent at settings involving 180 or 190 uL dilution volumes.

MANUFACTURER: Mallinckrodt Medical, Inc., County Westmeath, Ireland.

PRODUCT: Shiley "Tracheosoft" Extended Length Disposable Cannula Tracheostomy Tubes, indicated for use in providing tracheal access for airway management: a) Extended Length Cuffed Tracheostomy Tube, Catalog No. XLDT and XLTP b) Extended Length Cuffless Tracheostomy Tube, Catalog No. XCSD and XCSP c) Extended Length Disposable Inner Cannula, Catalog No. XIC Recall #Z-833/835-9.

REASON: Conditions such as head base and flange may separate and disconnect from the outer cannula tube or the extended length disposable inner cannula tubing may separate from the connector during use which could result in a loss of airway.

MANUFACTURER: Guidant Corporation, Cardiac Pacemakers, St Paul, Minnesota.

PRODUCT: Discovery and Meridian Multiprogrammable Pacemakers, intended for use in patients who are symptomatic due to atrial and ventricular bradyarrhythmias: Varies names and model numbers. Recall #Z-836/841-9.

REASON: The devices have a high current drain that prematurely depletes the battery power, resulting in no telemetry, pacing in backup mode, premature battery replacement, and no output conditions.
 

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