Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

FDA Recalls

August 2, 2000 - October 11, 2000

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 11, 2000:

CLASS II

MANUFACTURER: Datex-OHMEDA Inc., Tewksbury, Massachusetts.

PRODUCT: Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU), a complee anesthesia delivery unit with electronically controlled ventilator, gas delivery and agent vaporizing units. Recall #Z-004-1.

REASON: The device has reliability problems with fresh gas delivery, agent delivery and ventilation functions.

CLASS III

MANUFACTURER: Pharmacia & Upjohn Groningen BV, Groningen, Netherlands.

PRODUCT: CeeOn Intraocular Lens, heparin surface modified IOL. Recall #Z-002-1.

REASON: The label states the lens has a diameter of 6.5mm while the actual diameter of the lens is 6.0mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 4, 2000:

CLASS II

MANUFACTURER: Howmedica Osteonics Corporation, Rutherford, New Jersey.

PRODUCT: Centrex Bipolar Endoprothesis Comp, used in conjunction with a femoral stem component in the reconstruction of a femoral head damaged by fresh fracture non-union aseptic necrosis of the femoral head and neck or by osteoarthritis or post-traumatic arthritis. Recall #Z-963-0.

REASON: A 26mm UHWPE insert was issued instead of a 28mm insert.

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

PRODUCT: Titanium Roof Pile Screw, Catalog #1001-05-501, intended for use to fixate Depuy Protrusio Rings. Recall #Z-1022-0.

REASON: The device was incorrectly labeled as sterile when it was not properly sterilized.

MANUFACTURER: Electric Mobility Corporation, Sewell, New Jersey.

PRODUCT: Power Chairs: a) Rascal Model Numbers RAS 545 and RAS 445; b) Chauffeur Model Numbers: P48, S45, X48, and X48E. Recall #Z-1029/1030-0.

REASON: The Power chairs' controller program does not meet the original engineering specifications.

MANUFACTURER: Becton Dickinson Microbiology Systems, Cockeysville, Maryland.

PRODUCT: Isoniazid drug lot No. 9335260 used in the following kits: BACTEC (tm) S.I.R.E. Drug Kit used for susceptibility testing of Mycobacterium tuberculosis, Catalog No. 442102, Lot Nos. 9327296, 93442298, 9327298; BACTEC (tm) Isoniazid Drug Kit used for isoniazid susceptibility testing, Catalog No. 442146, Lot No. 9327297. Recall #Z-1032-0.

REASON: Some bottles of the products listed above are labeled Isoniazid but actually contain Streptomycin.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff, UK.

PRODUCT: Vitros Immunodiagnostic Products brand of: Prolactin Reagent Pack, 100 test units per pack Catalog No. 184 9793; and associated Vitros Prolactin Calibrators, Catalog No. 111 3596, for in vitro diagnostic use only. Recall #Z-1023/1024-0.

REASON: Calibration failures may occur when using this lot of product due to lower than expected light unit output for the level 1 calibrator.

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

PRODUCT: Replace 4.3mm Conical Abutment, 4.3mm diameter x 4.5 mm height, Catalog #43503. An abutment is used either for single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1025-0.

REASON: The conical abutment was not the size as labeled.

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

PRODUCT: IMC (Intramobile Connector) Conversion Screw, 3.5mm diameter, Catalog #8198CA. An IMC cylinder is used for either single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1026-0.

REASON: The screw in the package is incorrect.

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

PRODUCT: Gold Cylinder Fastening Screw, 3.3mm diameter x 12 mm height. Catalog #8905A. an IMC cylinder is used either for single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1027-0.

REASON: The screw in the package is incorrect.

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

PRODUCT: Replace 4.3mm Conical Abutment, 4.3mm diameter x 1.5mm height, Catalog #43500. An abutment is used either for single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1028-0.

REASON: The conical abutment was not the size as labeled.

MANUFACTURER: Metrex Research Corporation, Parker, Colorado.

PRODUCT: ProCide-D Plus Sterilizing & Disinfecting Solution. Recall #Z-1031-0.

REASON: Part of the subject lot was mislabeled as Procide-D Plus, which contains3.4% glutaraldehyde, rather Procide-D, which contains 2.5% glutaraldehyde.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 27, 2000:

CLASS II

MANUFACTURER: Ethicon, Inc., Somerville, New Jersey.

PRODUCT: Endopouch Pro Specimen Retrieval Bag, Model PRO46. Recall #Z-910-0.

REASON: Breakage of the metal rim, bags not sealing, and bag breakage.

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

PRODUCT: ImmunoCard Rotavirus, an ELISA diagnostic test kit for the detection of Rotavirus antigens in human stool. Recall #Z-049-0.

REASON: The conjugate concentration is too high resulting in false positive test results.

MANUFACTURER: Becton Dickinson Critical Care Systems PTE Ltd., Singapore.

PRODUCT: Becton Dickinson Exacta Percutaneous Sheath Introducer Kits, for the introduction or insertion of pulmonary arterial catheters into the vascular system: a) KIT-012-00; b) KIT-009-01; c) KIT-010-00; d) KIT-012-00; e) KIT-009-00. Recall #Z-954/958-0.

REASON: Introducer kits contain Clinipad components labeled as sterile.

MANUFACTURER: Enthox Corporation, Buffalo, New York.

PRODUCT: Compact Specialty Feeding Tubes 22 French CALUSO PEG Deluxe Tube Kits, Product Number 097022 Compact Specialty Feeding Tubes 22 French NUPORT PEG Deluxe Tube Kits, Product Number 097522 Compact Specialty Feeding Tubes 15 French PEDI PEG Deluxe Tube Kits, Product Number 084015 For distribution in Europe, the products are: Compat PEG 22 French Reference Number 052001 (the equivalent to the 22 French CALUSO PEG in the kit distributed in the U.S.) Compat NUPORT-PEG French, Reference Number 052005 (this is equivalent to the 22 French NUPORT PEG in the kit distributed in the U.S.) Compat PEG 15 French, Reference Number 052000 (this is equivalent to the 15 French PEDI PEG in the kit distributed in the U.S.). The PEG's in the European and U.S. kits are the same, but some of the other components in the kits are different. The PEG tubes are percutanous endoscopic gastrostomy devices intended to provide gastric access portals for the administration of enteral feeding formulas. Recall #Z-959/961-0.

REASON: Gastrostomy tube can separate from dilator tube during placement.

MANUFACTURER: Medtronic Physio-Control Corporation, Redmond, Washington.

PRODUCT: Non-rechargeable lithium battery for use with the lifepak 500 Automate External Defibrillator. LP 500 is designed to be used by first responders to cardiac emergencies, including fire and police personnel. The LP500 is also used by trained personnel on commercial airlines. Recall #Z-962-0.

REASON: Battery failure due to battery cell rupture causing battery pack case to split. Recall #Z-962-0.

MANUFACTURER: Meridian Diagnostic, Inc. Cincinnati, Ohio.

PRODUCT: Premier Rubeola IgG ELISA, an in-vitro diagnostic test kit for the qualitative detection of IgG Antibody to Rubeola Virus in Human Serum. Recall #Z-964-0.

REASON: Reference control does not meet specs, and may lead to false negative results.

MANUFACTURER: Maxxim Medical, Inc., Athens, Texas.

PRODUCT: Angiography Drape Pack, Advantec-MLD Angiography Procedure System: a) Product 500501; b) Product 500502; c) Product 500503; d) Product 500504; e) Product 500505; f) Product 500506; g) Product 500507; h) Product 500508; I) Product 500509; j) Product 500502A; k) Product 500502B l) Product 500504A; m) Product 500504B. Recall #Z-965/977-0.

REASON: Particulate mater may be present.

MANUFACTURER: Becton Dickinson Microbiology Systems, Cockeysville, Maryland.

PRODUCT: a) BBL Crystal (tm) Gram-Positive ID System, Catalog #245140 (for export only) and 245240, a miniaturized identification method for ID of aerobic gram positive bacteria; b) BBL Crystal (tm) Neisseria/Haemophilus ID Systems, Catalog #245130, a miniaturized identification method for ID of Neisseria, Haemophilus, and other fastidious bacteria. Recall #Z-981/982-0.

REASON: Microbilogical IVD tests misidentified bacteria in samples.

MANUFACTURER: Instrumentation Industries, Inc., Bethel Park, Pennsylvania.

PRODUCT: Diaphragm Assembly consisting of a silicone rubber balloon, a polypropylene stem, and polypropylene ring. The ring secures the balloon to the stem. The diaphragm assembly is a sub-component of an exhalation valve, which is designed for use with ventilators to regulated gas flow. Exhalation valves are used to prevent inspired gases from escaping through the passage that will be made available to expired gas via an inflatable balloon. Re-breathing of the expired gases is prevented by the balloon action. Recall #Z-9830-0.

REASON: The rings used in the diaphragm assembly were inadvertently molded with the wrong core pin.

MANUFACTURER: Alexon-Trend, Inc., Ramsey, Minnesota.

PRODUCT: SERADYN Color Slide Rubella 100 Test Kit, Product Number 0371005, 100 Test, a rapid latex particle agglutination test for the qualitative and semi-quantitative determination of IgG and IgM antibodies to Rubella Virus in serum. Recall #Z-984-0.

REASON: Positive controls do not meet specifications in 3-month stability testing.

MANUFACTURER: Xomed, Inc., Jacksonville, Florida.

PRODUCT: Pulsatron II Disposable Nerve Locator, Catalog # 82-62105 This is a battery operated disposable nerve stimulator/locator intended to stimulate moto nerves exposed during surgery for the purpose of identification or loaction. Recall #Z-985-0.

REASON: Failure to function or intermittent function during use.

MANUFACTURER: Encision, Inc., Boulder, Colorado.

PRODUCT: a) Electroscope ES-0001 (1/2") Scissors Insert Electroscope; b) ES-0002 (3/4") Scissors Insert Reusable scissors inserts, part of Electroscope's AEM System, which consists of a monitoring device, interconnecting cords and adapters, and electrosurgical instruments with integrated shield. Instrument inserts of various tip styles are available, including the 1/2" and 3/4" reusable scissors. Recall #Z-987/988-0.

REASON: Scissors inserts for electrosurgical instrument could come apart during use.

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

PRODUCT: InnerDyne, Inc., One-Step Percutaneous Dilator with Sheath, intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative procedures. Recall #Z-989-0.

REASON: Compromised sterile barrier on the lid-stock of sealed product trays.

MANUFACTURER: Otto Bock Orthpedische Industrie, Duderstadt, Germany

PRODUCT: Otto Bock Modular Knee Joints, Model 3R36, used for lower limb amputees up to 220 pounds body weight, and with moderate activity levels. Recall #Z-990-0.

REASON: The prosthetic knee joint could fail due to setscrews, which can come loose.

MANUFACTURER: Norian Corporation, Cupertino, California.

PRODUCT: Norian Pneumatic Mixer, used in conjunction with Norian Reactant Pack by automatically preparing Reactant Pack constituent components for transfer of mixed cement paste into sterile filed. a) Item #MXR-1000 Pneumatic Mixer Assembly b) Item #MXR-PNE01-UNV Pneumatic Mixer Assembly c) Item #5-MXR-1000 Pneumatic Mixer Assembly. Recall #Z-992/994-0.

REASON: The sterility of the product may be compromised as evidenced by a loss of package integrity.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft, human heart valve replacement implant: a) Model No. AV05; b) Model No. PV05. Recall #Z-997/998-0.

REASON: Serodilution of plasma.

MANUFACTURER: Bivona Medical Technologies, Gary, Indiana.

PRODUCT: Customized Flextend (tm) Tracheostomy Tubes, with standard Curve, wire reinforced distal shafts. Recall # Z-999-0.

REASON: The curved, wire-reinforced distal shaft fails to remain curved.

MANUFACTURER: Ameriwater, Dayton, Ohio.

PRODUCT: Dialysis Reverse osmosis Water System, a single/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify potable water for use in making dialysate for hemodialysis: Model Numbers: MROS, MRO1, and MR02. Recall #Z-1000/1002-0.

REASON: The RO system experiences a low draw-rate of peroxide/ peroxyacetic acid (PAA) during sanitization of system.

MANUFACTURER: Wuestec Medical, Inc., Mobile, Alabama.

PRODUCT: Dr. Sweat's Atlas Orthogonal Chiropractic Adjustment Table (also known as Atas Table), used to adjust the nect of chiropractic patients. Recall #Z-1003-0.

REASON: Manufacturing defect could cause patient to be pinned by stylus to adjustment table.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft, heart valve. Recall #Z-1004-0.

REASON: Donor possessed adenocarcinoma of the prostate.

MANUFACTURER: Nitinol Medical Technologies, Inc., Boston, Massachusetts.

PRODUCT: 33-mm CardioSeal Septal Occluder Implant (Sterile), designed to close intra-aortic defects percutaneously with the assistance of a Delivery System. Recall #Z-1005-0.

REASON: Mislabeled as 33-mm vs 17-mm Septal Occluder Implant.

MANUFACTURER: Kensey Nash Corporation, Exton, Pennsylvania.

PRODUCT: Angio-Seal Vascular Closure Device 6 French, Model 610091, for use in closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a French or smaller procedural sheath. Recall #Z-1008-0.

REASON: Device crimp stop can slip.

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-1009-0.

REASON: The test ports of the cards may exhibit false negative results.

MANUFACTURER: Stryker Medical, Kalamazoo, Michigan.

PRODUCT: Stryker Rugged MX-Pro Ambulance Cots, a wheeled stretcher intended for EMS use: a) Model No. 6070; b) Model No. 6080. Recall #Z-1010/1011-0.

REASON: The safety bar return springs located at the head end of the cots have failed.

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

PRODUCT: Model Elite/Corium Laser System, various uses including dermatology, dentistry, ophthalmology, ENT, etc. Recall #Z-1020-0.

REASON: Noncompliant calibration procedures in the operator's manuals.

UPDATE 

Insyte AutoGuard IV Catheter, Recall #Z-923/936-0 which appeared in the September 13, 2000 Enforcement Report should read: DISTRIBUTION: Nationwide, Argentina, Asia Pacific, Australia, Brazil, Canada, Europe, Japan, Mexico. REASON: Localized skin irritation at catheter insertion site.

MEDICAL DEVICE SAFETY ALERT UPDATE 

The Trima Automated Blood Component Collection System manufactured and distributed by Gambro BCT, Inc. lakewood, Colorado, which was listed under "MEDICAL DEVICE SAFETY ALERT in the 9/13/00 Enforcement Report, is NOT being recalled. The action is a firm initiated Safety Alert and consists of a letter of August 4, 2000 providing additional safety usage instructions. Each customer will also receive a revised Operator's Manual which will have emphasized instructions for the safe use of the device. Page 8 of 8

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 20, 2000:

CLASS II

MANUFACTURER: Olympus Opto-Eectronics, Ltd. – Aizu Factory, Fukushima-

ken, Japan.

PRODUCT: Cleaning Brush (BW-9Y) for the Olympus SIF-Q140 Video Enteroscope, used for cleaning the endoscope’s distal end when inserted through the suction channel (s-cylinder).

Recall #Z-912-0.

REASON: Manufacturing defect – cleaning brush too short.

MANUFACTURER: Millar Instruments, Inc., Houston, Texas.

PRODUCT: a) 6 Fench Disposable Angiographic Cathers; b) 6 French Special Catheters.

Recall #Z-915/916-0.

REASON: Presence of small fibers that may shed during use. These catheters were used as components in the Millar devices.

MANUFACTURER: Bio-Plexus, Vernon, Connecticut.

PRODUCT: Punctur-Gard Revolution Safety Needle Holder, used in conjunction with the Punctur-Guard Blood Collection Needle.

Recall #Z-918-0.

REASON: Holder may fail to activate needle safety mechanism.

MANUFACTURER: Medtronic Ave, Inc., Danvers, Massachusetts.

PRODUCT: Medtronic 6F SiteSeer Agiographic Catheter, used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessel.

Recall #Z-919-0.

REASON: Sterility of the device is compromised due to an improperly sealed pouch.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff.

PRODUCT: Testosterone Reagent Pack, 100 test units per pack, for in-vitro diagnostic use only, intended for the in-vitro quantitative measurement of testosterone in human serum and plasma.

Recall #Z-920-0.

REASON: Test results may be identified as ng/mL when results are for ng/dL.

MANUFACTURER: Boston Scientific Scimed, Inc., Maple Grove, Minnesota.

PRODUCT: Maxxum PTCA Dilation Catheters (Balloon Catheters) Catalog #H74914497300 (20 mm) and Catalog #H74914496300 (13mm), percutaneous transluminal coronary angioplasty catheters used to dilate coronary artery stenoses or previously placed stents.

Recall #Z-942/943-0.

REASON: Balloon PTCA Catheters were mislabeled as to length.

MANUFACTURER: Instrumentation Industries, Inc., Bethel Park, Pennsylvania.

PRODUCT: BE-148-4 Cuff Pressure Monitor.

Recall #Z-945-0.

REASON: There is a tight fit between small port and mating part (pilot line check valve) which precludes a connection.

MANUFACTURER: Instrumentation Industries, Inc., Bethel Park, Pennsylvania.

PRODUCT: BE-148-4 Cuff Pressure Monitor.

Recall #Z-945-0.

REASON: There is a tight fit between small port and mating part (pilot line check valve) which precludes a connection.

MANUFACTURER: Drager Medizintechnik GmbH (DMT) Lubeck, Germany.

PRODUCT: Incubator 8000 NC/SC/IC (Neotatal Incubator) and Radiant Heater RH600 (Infant Radiant Heater). The heater was sold separately and could have been mounted to the incubator, floor stand or wall.

Recall #Z-946/947-0.

REASON: The skin temperature sensor for the incubator 8000 is not working properly.

MANUFACTURER: Applied Medical Resources, Laguna Hills, California.

PRODUCT: Radiolucent Threaded Cannula (5mm X 10mm), an endoscopic device that provides access to the patient’s peritoneal cavity and allows insertion of endoscopic instruments and the removal of specimens.

Recall #Z-948-0.

REASON: This device has the potential to crack in the shaft of the cannula over time.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch

Cardiff.

PRODUCT: TSH Reagent Pack, Catalog #191 2997, intended for the in vitro quantitative measurement of thyroid stimulating hormone in human serum and plasma to aid in the differential diagnosis of thyroid disease.

Recall #Z-917-0.

REASON: Reagent instability caused negative bias with control and/or patient samples

MANUFACTURER: C.R. Bard, Inc., Queensbury, New York. 

PRODUCT: Tigertail Flexible Tip Ureteral Catheter labeled to contain 6 Fr. Catheters, used to facilitate urinary drainage from the kidney and/or injection of contrast media into the kidney.

Recall #Z-938-0.

REASON: Package labeled as 6 FR. Catheters, contained 4 Fr. Catheters.

MANUFACTURER: Utah Medical Products, Inc., Midvale, Utah.

PRODUCT: Utah Medical Products, Deltran IV-Plus Pressure Monitoring Kit, Catalog No. ABC-448-6.

Recall #Z-944-0.

REASON: Kits were mislabeled as an obstetric vaccum kit

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

PRODUCT: Abbott AxSYM Estradiol Reagent Pack, List 7A63-20, 10-test kit; an in-vitro diagnostic microparticle enzyme immunoassay (MEIA) for the quantitative determination of estradiol in human serum on the AxSYM System.

Recall #Z-950-0.

REASON: Depressed estradiol results when using the undiluted protocol.

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

PRODUCT: IMx Estradiol Reagent Pack, List 2215-22, 100-test kit; an in-vitro diagnostic microparticle immunoassay (MEIA) for the quantitative determination of estradiol in human serum or plasma on the IMx analyzer.

Recall #Z-951-0.

REASON: Depressed estradiol results when using the undiluted protocol.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff.

PRODUCT: Vitros Immunodiagnostic – TSH Reagent Pack, 100 tests per pack, for the invitro quantitative measurement of thyroid stimulating hormone in human serum and plasma.

Recall #Z-952-0.

REASON: Some TSH Reagent packs may contain incorrectly labeled reagent bottles.

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

PRODUCT: Medtronic Sigma SDR303 and SS303 Implantable Pulse Generators, used for the restoration of heart rhythm.

Recall #Z-979/980-0.

REASON: Final device programming does not match the label identification.

MANUFACTURER: Exactech, Inc., Gainesville, Florida.

PRODUCT: AcuMatch C-Series Cemented Femoral Component, Size 6 (Originally named the Exactech AuRa Hip System Femoral Component but has been renamed AcuMatch C-Series), hip implant, femoral component-these stems are intended to be used with bone cement for the treatment of skeletally mature individuals undergoing primary surgery for total hip replacement.

Recall #Z-986-0.

REASON: Products were mislabeled with the incorrect stem length.

MANUFACTURER: Datascope Corporation, Fairfield, New Jersey.

PRODUCT: Datascope 9.5 Fr. 34 cc True Sheathless Intra-Aortic Balloon Catheter with 10 Fr. 6-inches Sheath, Model #0684-00-0314-01.

Recall #Z-1012-0.

REASON: The outside user label on the product describes the insertion kit as containing a 10 Fr. 11" catheter introducer instead of correctly identifying it as containing a 10 Fr. 6" catheter introducer.

MANUFACTURER: Zimmer, Inc., Warsaw, Indiana.

PRODUCT: Zimmer ZMR Hip System Implant Assembly Guide, Catalog #00-9975-043-00, used to record the orientation of the proximal body and distal stem implant provisionals for later assembly of the final implant components.

Recall #Z-1013-0.

REASON: The product was found adulterated and misbranded, in that the alignment arrow was oriented incorrectly on the component.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 13, 2000: 

CLASS II

MANUFACTURER: Bayer Corporation, Medfield, Massachusetts.

PRODUCT:  Troponin I Immunoassay, used in the quantitative determination of cardiac Troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the ACS: 180 and ADVIA Centaur Automated Chemiluminescene System: ACS: 180 SYSTEMS AND ADVIA CENTAUR TOPONIN I Part # 110631 ACS:180 Troponin I 50T KitPart # 110632 ACS:180 Troponin I 300 KitPart # 116993 ADVIA Centaur Troponin I 100T KitPart # 116994 ADVIA Centaur Troponin I 500 T Kit.

Recall #Z-886/889-0.

REASON:Revised instruction for use due to false positive results.

MANUFACTURER: Image Guided Technologies, Inc., Boulder, Colorado.

PRODUCT: IGT 135mm Wireless Probe, (a pointer), an accessory to Carl Zeiss’ image guided surgery system.

Recall #Z-907-0.

REASON: Trajectory deviation of wireless probe. The line of sight trajectory for this pointer follows the angle of the bayonet, while the tracking system trajectory follows the line from the LED’s to the tip of the bayonet in a straight line.

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

PRODUCT: Ultramix Mixing Bowl Single Mix CMW, Catalog #5401-59-000, intended for use in mixing bone cement.

Recall # Z-911-0.

REASON: There is a possible packaging anomaly that may allow for a non-sterile condition within the packaging or on the outside of the mixing bowl.

MANUFACTURER: Abbott Laboratories, Inc., Bedford, Massachusetts.

PRODUCT: a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication.

Recall #Z-913/914-0.

REASON: Glucose values greater than 600 mg/dl are downloaded incorrectly.

MANUFACTURER: Hewlett-Packard Company, Andover, Massachusetts.

PRODUCT: Hewlett Packard (HP) M1465A Airway Adapter, accessory to carbon dioxide gas analyzer, intended to provide a breath-through gas sample cell for making C02 concentration measurements as part of the HP C02 monitoring systems for patients weighing more than 10 kg.

Recall #Z-921-0.

REASON: Airway adapter out of dimensional specification which may result in air leak.

MANUFACTURER: Life-Tech Intl., Inc., Stafford, Texas.

PRODUCT: 1524, Tumisensor, all sizes, used for the diagnosis and treatment of erectile dysfunction.

Recall #Z-022-0.

REASON: Product does not comply with performance standard: Electrode Lead Wires/Patient Cables, in that the connections are exposed.

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, Utah.

PRODUCT: Insyte AutoGuard IV Catheter, intravascular catheter to be inserted into the patient’s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids intravenously: Catalog No’s. 381412, 381423, 381433, 381434, 381437, 381444, 381447, 381454, 381457, 381512, 381523, 381533, 381534, 381544.

Recall #Z-923/936-0.

REASON: Localized skin irritation and infection at catheter insertion site.

MANUFACTURER: Siemens Medical Systems, Inc., Danvers, Massachusetts.

PRODUCT: Sp02 Extension Cables (Part Number 33 68 433 E530U AND 33 75 835 E530U) used with Siemens Patients Monitors: SC7000, SC8000, SC9000XL, and SC6002XL AND MIXED MONITORS-SC9000 or SC5000/6000 with SC7000, SC8000, SC900X OR SC6002XL. Cables are connected to sp02 sensors and to either multimed or neomed pods are then connected to monitors.

Recall #Z-937-0.

REASON: Older versions of the Sp02 Extension Cables may result in high Sp02 readings.

MANUFACTURER: Stryker Puerto Rico, Arroyo, Puerto Rico.

PRODUCT: Strykeflow Suction Irrigator II, Model/Part #250-070-500, Intended for use in laparoscopic general surgery, laparoscopic gynecological surgery and nasal surgery.

Recall #Z-939-0.

REASON: Loss of sterility is possible.

MANUFACTURER: Sandhill Scientific, Inc., Highlands Ranch, Colorado.

PRODUCT: Sandhill Scientific Schuster Anorectal Manometry Probe: a) Schuster Anorectal Probe (Adult); b) Schuster Anorectal Probe (Pediatric).

Recall #Z-940/941-0.

REASON:Labeling for internal and external balloons was reversed.

MEDICAL DEVICE SAFETY ALERT

PRODUCT: COBE BCT brand Trima Automated Blood Component Collection System, a transportable automated system that separates whole blood from a donor into its major components.

Safety Alert #N-017-0.

CODE:  Catalog #91700-000, All serial numbers.

MANUFACTURER: GAMBRO BCT, Inc., Lakewood, Colorado.

RECALLED BY: Manufacturer, by letter on August 4, 2000, and by letter. Firm-initiated recall ongoing.

DISTRIBUTION  :  Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chili Dominican Republic, Egypt, France, German, Ireland, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, Turkey, United Kindom and Uruguay.

QUANTITY- 450 UNITS

REASON: Failure to follow instructions could cause air embolism

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 23, 2000:

CLASS II

MANUFACTURER: Casix, Inc., Chatsworth, California.

PRODUCT: Laser Pointers, wide range in academic, industry and consumer use: a) Model DPCL; b) Model DPIR. Recall #Z-881/882-0.

REASON: Noncompliance with performance with the Federal laser product performance standard, 21 CFR 1040.10 in that products lack beam atenuators, emission indicators, remote interlock connectors, and required labeling.

MANUFACTURER: JDS Uniphase, Manteca, California.

PRODUCT: Diode-pumped solid state micro lasers, for various uses including academia and industry applications. Recall #Z-883/885-0

REASON: The laser product failed to comply with the Federal laser product performance standard, 21 CFR 1040.10 in that the following deficiencies: beam attenuator, key control, emission indicator, remote interlock connector and labeling.

MANUFACTURER: Aquarius Medical Corporation, Scottsdale, Arizona.

PRODUCT: a) Baxter Thermo (tm) Stat Hypothermia Warming Mitt/Seal (Hand Model), Catalog No. 10-1005/IT0310; b) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalog No. 06-0003/IT0311; c) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalog No. TR-04004/ETR-04004. Recall #Z-891/893-0.

REASON: Water evaporates through the polyvinyl chloride bag over extended periods of storage, leading to a higher salt concentration with increase in mitt temperature, with possible thermal injury to the patient.

MANUFACTURER: Bear Medical Systems, Palm Spring, California.

PRODUCT: Bear 1000 Ventilator, an adult/pediatric ventilator intended to provide continuous mechanical ventilation of adult and pediatric patients: a) Catalog #50-08550; b) 50-08555; c) 50-08560; d) 50-08570. Recall #Z-894/897-0.

REASON: There is possible corrosion of the mechanical relay that activates the loss of power alarm.

MANUFACTURER: Fukuda Denshi Company, Ltd., Tokyo, Japan.

PRODUCT: Fukuda Denshi, Model DS-5300 Patient Monitor, used to monitor one or more of the following on an individual patient: ECG, respiration, non-invasive and/or invasive blood pressures, temperature, pulse oximetry and cardiac output. Recall # Z-898-0.

REASON: Power supply sub-assembly may fail causing the DS 5300 Patient Monitor to become inoperable.

MANUFACTURER: Zimmer, Inc., Warsaw, Indiana.

PRODUCT: Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, intended for cemented or non-cemented use in adults undergoing primary surgery for rehabilitating hips: a) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, Standard, 28 mm I.D., for use with 60 mm 0.D. Shell, Catalog No. 00-6305-060-28; b) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, 7mm Ofset, 32 mm I.D., for use with 70- mm O.D. Shell, Catalog No. 00-6341-070-3. Recall #Z-900/901-0.

REASON: 70 mm liners are inside a 60 mm package.

CLASS III

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

PRODUCT: Merifluor VZV IgM IFA/IFT, a rapid imunofluorescence test kit for the detection of IgM antibodies to varicella-zoster virus (VZV) in human serum. Recall #Z-902-0.

REASON: The VZV IgM IFA/IFT test kits are incorrectly labeled as EBV IgM IFA/IFT kits.

MANUFACTURER: Oxoid Ltd., United Kingdom

PRODUCT: Cephalothin Susceptibility Test Disks, KF 30. Recall #Z-903-0.

REASON: Product was labeled as Cephalothin Susceptibility Test Disks but contained Vancomycin Susceptibility Test Disks.

MANUFACTURER: Recalled By: - Aspen Surgical Products, Inc., Grand Rapids, Michigan, by telephone between October 21-28, 1999, followed by fax. Firm-initiated recall complete.

PRODUCT: Richard Allan Dispos-a-Ture Needles, Eyed Surgical Needles, Mayo Catgut 1/2 Circle Taper Point (Heavy), a disposable suturing needle. Recall #Z-904-0.

REASON: The outer boxes are labeled to contain, and do contain, product #216705, the individual pouches within the boxes are labeled as product 216706. The two needles are different sizes.

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

PRODUCT: Architect I 2000 System. Recall #Z-906-0.

REASON: System allows running of samples while the automatic flushing/cleaning occurs.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 16, 2000:

CLASS II

MANUFACTURER: MAS, Inc., Camarillo, California.

PRODUCT: Abbott Multiconstitutent Calibrator, List #IE65-01, for in-vitro diagnostic use. Recall #Z-878-0.

REASON: A shift in control values on Creatinine assay.

MANUFACTURER: CASCO/NERL Company, East Providence, Rhode Island.

PRODUCT: Abbott A-GENT Uric Acid Standard Kit, for in-vitro diagnostic use. Recall #Z-879-0.

REASON: The standard labeled 6mg/dL is recovering at approximately 5mg/dL. Use of these Standards on the spectrum instrument will result in a calibration failure.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 9, 2000:

CLASS II

MANUFACTURER: Roche Diagnostics GmbH, Penzburg, Germany.

PRODUCT: Elecsys HGC STAT Immunoassay, a pregnancy test kit for use on Roche Elecsys analyzers.

Recall #Z-835-0

REASON: There is an incidence of false elevation in pregnancy test results for the above method that is not related to HAMA (human anti-mouse antibody) interference. This effect manifests as a repeatable positive result that cannot be confirmed by alternative methodologies.

MANUFACTURER: Sanofi Diagnostics Pasteur, Coquette, France.

PRODUCT: Access brand immunoassay Reagent Packs, in-vitro diagnostic medical devices:

a) Beckman Coulter Access Troponin I brand Immunoassay System Reagent Pack;
b) Beckman Coulter Access CEA brand Immunoassay system reagent pack;
c) Beckman Coulter Access PSA brand Immunoassay system reagent pack;
d) Beckman Coulter Access Rubella IgG brand Immunoassay system reagent pack;
e) Beckman Coulter Access Toxoplasma IgM Brand Immunoassay system reagent pack.

REASON: The above reagent packs may have been improperly filled or contain an incorrect reagent component.

MANUFACTURER: Baush & Lomb Surgical, Claremont, California.

PRODUCT: Chiron Vision SoFlex Foldable UV-Absorbing Posterior Chamber Silicone Intraocular Lens, Model L151U.

Recall #Z-880-0.

REASON: The lenses were polished using an incorrectly prepared polishing mixture that resulted in the lens causing a cloudy visual acuity for the patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 2, 2000:

CLASS II

UPDATE

Recall #Z-754/755-0, which appeared in the June 29, 2000 Enforcement Report and as an update on July 5, 2000, should read: PRODUCT: SYSMEX CA-10000 and SYSMEX CA-5000 Automated Coagulation Analyzer.

MANUFACTURER

Sysmex Corporation, Kobe, Japan.

RECALLED BY

Sysmex Corporation of America, Long Grove, Illinois.
 

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map