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FDA Recalls

Attention all mdi Clients:

FDA Recalls by week, August - October 1999

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 27, 1999

CLASS II

MANUFACTURER: Bayer Diagnostics, E. Walpole, Massachusetts

PRODUCT: ACS: Centaur TROPONIN I IMMUNOASSAY (cTnI), for 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 Chiron Diagnostics ACS: Centaur Chemiluminescence System, for In-Vitro Diagnostic use. Recall #Z-1263-9.

REASON: Controls and patient samples were recovering higher results than expected range.

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

PRODUCT: Dill Guide. Recall #Z-017-0.

REASON: The cannulated center of the drill guide may not allow drill bit to pass through.

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

PRODUCT: Blunt Side Opening Screw. Recall #Z-018-0.

REASON: The screws from the production lot were manufactured at greater length than specified.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Reaming Rods with Offset, Straight and Smooth Tips and Medullary Part Numbers: a) 351.71S b) 351.76S c) 355.041S d) 355.01S Recall #Z-019/022-0.

REASON: In some sterile packages, the sterility may be compromised.

MANUFACTURER: Orion Life Systems, Inc., Wheeling, Illinois (trays); Jiang Su Jin Hong Corporation, Jintan City, Jiangsu, China (gauze).

PRODUCT: a) Orion Tracheostomy Care Kit with 14-16 FR Catheter b) TRACHEOSTOMY CARE KIT; sterile, single patient use trays; reorder #3017. Recall #Z-024/025-0.

REASON: Gauze may be contaminated with ETO resistant mold.

MANUFACTURER: Nucletron BV, The Netherlands.

PRODUCT: Nucletron Plato External Beam Planning Radiation Therapy Software V2.1.2 and MLC/Shape Software Module V2.3 Recall #Z-038-0.

REASON: Coordinates for radiation beam used in therapy are mislabeled in software.

MANUFACTURER: Nucletron BV, The Netherlands.

PRODUCT: Plato Brachytherapy Treatment Planning System Recall #Z-039-0.

REASON: Software implementation error.

MANUFACTURER: Inovo, Inc., Naples Florida.

PRODUCT: Oxygen Pressure Regulator, Models: 3125R1GREEN, 3125R2GREEN, 8725R2BLACK, 51B2215R2, 3125R2SILVER, 8700R1GREEN, 3125L1GREEN, 51B2215L1, 3125L1GREEN, 51B2225LD1 AND 51B2225L1, L106-260, L270-220/240, L370-220-A, -B, -G, -GL and -R. Recall #Z-041/059-0.

REASON: Faulty DISS fittings causing inadequate flow.

MANUFACTURER: Hudson Respiratory Care, Inc. Temecula, California.

PRODUCT: Bacterial/Viral Filters, used to filter air/gas on mechanical ventilators and anesthesia gas machines to provide an added means of cross-contamination protection: a) Bacterial/Viral Filters, Catalogue No. 1605 b) Bacterial/Viral Filters, Catalogue No. 7178. Recall #Z-062/063-0.

REASON: The filters were manufactured by ultrasonic welders that were operating out of a state-of-control causing some over-welding conditions to occur, compromising the filter's efficiency.

UPDATE

Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay, Recall #Z-1257/1258-9, recalled by Dade Behring, Inc., which appeared in the September 29, 1999 Enforcement Report should read: REASON: Product may produce false positive and false negative test results.

CLASS III

MANUFACTURER: Alcon Surgical, Inc., Huntington, West Virginia.

PRODUCT: UV Asorbing Posterior Chamber Intraocular Lens: a) Model MC20BA b) MC60CM Recall #Z-007/008-0.

REASON: Mislabeling of registration number required for distribution of product in Japan. Label does not include information necessary for proper use of product.

MANUFACTURER: VIA Medical Corporation, San Diego, California.

PRODUCT: VIA ABG & Chemistry Cal Kit, an accessory used to calibrate the VIA Blood Chemistry Monitoring System prior to patient attachment and during monitoring of patient. Recall #Z-028-0.

REASON: An inappropriate calibration reference number was assigned to the lot of kits, which could affect the measurement of the pH parameter.

MANUFACTURER: Eastman Kodak Company, Rochester, New York.

PRODUCT: Radiographic Film Cassettes with Intensifying Screens for Mammography: Varies name cassettes and catalog numbers. Recall #Z-029/034-0.

REASON: The above-referenced cassettes potentially cause a small density variation of approximately 0.3 overall density between mammography films due to a change in supply of a small plastic strip that keeps the cassette foam in place.

MANUFACTURER: Instrumentation Laboratory Company, Milan, Italy.

PRODUCT: Reference Electrode Disposable Membrane Caps, intended for use with the IL 1600 Series Blood Gas Analyzer. Recall #Z-035-0.

REASON: Mold contamination underneath membrane may cause stability issues.

MANUFACTURER: Radiometer Medical A/S, Copenhagen, Denmark. Sticker labeled by: Siemens-Elema AB.

PRODUCT: Siemens Accessory Set TCPO2+TCPCPO2 Probe, intended to continuously monitor noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population and to monitor oxygen in the neonatal population when the patient is not under gas anesthesia. Recall #Z-036-0.

REASON: Mislabeled -tcpo2 membrane kits labeled as tcp02/tcpC02 membrane kits.

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

PRODUCT: Total B-hCG Controls, for In-Vitro Diagnostic Use Recall #Z-037-0.

REASON: Control values are greater than the package insert ranges with AxSYM or IMx systems.

MANUFACTURER: Wesley Jessen Corporation, Des Plaines, Illinois.

PRODUCT: FreshLook DuraSoft Phemfilcon A 45%, water 55% Toric Contact Lenses for Astigmatism with Handling Tint; individually packaged sterile contact lenses for disposable or frequent replacement programs. Recall #Z-040-9.

REASON: Lenses were labeled with an axis of 90 degrees when they actually have an axis of 180 degrees.

MANUFACTURER: Cordis Corporation, Miami Lakes, Florida.

PRODUCT: Jupiter PTA Balloon Catheters a) Catalog #436502S b) Catalog #436452S Recall #Z-060/061-0.

REASON: The outer carton was mislabeled with incorrect dimensions on side panel.

MANUFACTURER: Nikon Optical Company, Ltd., Tokyo, Japan.

PRODUCT: Nikon Children's Eyewear Frames in various colors, Model KD5303. Recall #Z-072-0.

REASON: The rubberized end of the earpiece may separate from the frame exposing the metal support rod that runs through the earpiece.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 20, 1999:

CLASS II

MANUFACTURER: BLD Medical Products, Dallas, Texas PRODUCT: BLD PEEP-FLO resuscitator devices: a) Peep-Flo Positive Expiratory Pressure valve; b) Pulmanex Manual Resuscitator with a PEEP-FLOW Valve c) CPAP Chsuion-FLEX Mask packaged with BLD's PEEP-FLO ValveValve. Recall #Z-001/003-0

REASON: The PEEP-FLO valve values are out of specification.

MANUFACTURER: Pacific Device de Mexico, S.A.

PRODUCT: Sabraset 560112-L Administration Set with Spike and Cassette for use with the Sabratek 6060 Homerun Volumetric Infusion Pump only. Recall #Z-013-0.

REASON: Tubing may separate from the filter.

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

PRODUCT: Arrow Percutaneous Sheath Introducer Kit.

REASON: Potential for separation of sheath from hemostasis valve body in use.

MANUFACTURER: Zimmer, Inc., Dover, Ohio.

PRODUCT: ATS 2000 Pneumatic Tourniquet, intended use is to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

REASON: The buttons on the touch panel component may stick in position during use.

CLASS III

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

PRODUCT: ABBOTT AXSYM TROPONIN-I Reagent Pack; a microparticle enzyme immunoassay (MEIA), to assist in the diagnosis of acute myocardial infarction.

REASON: Calibration failures.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 13, 1999:

CLASS II

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: CryoValve Allograft Heart Valve. Recall #Z-004-0.

REASON: The firm's Quality Assurance has identified Donor 23718, received prior to 1/26/98, who does not meet the current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: CryoLife, Inc., Kenesaw, Georgia.

PRODUCT: CryoValve Allograft Heart Valve: a) Model AVOO b) Model PVOO Recall #Z-005/006-0.

REASON: Additional donor information on donor number 20995, not available at the time of release of the allografts, revealed that the donor's mother had tested positive for Hepatitis B Surface Antigen.

MANUFACTURER: T.H. Charters, Inc., Beaverton, Oregon.

PRODUCT: Precision Current Source Device, used in the dental field to stimulate bone growth and to act as an antibacterial agent. Recall #Z-009-0.

REASON: Product was distributed without a 510(k) or PMA.

MANUFACTURER: Airsep Corporation, Buffalo, New York.

PRODUCT: Oxygen Concentrators: Models AS005 and AS006-xx NOTE: "xx" = any 2-digit number. Recall #Z-010/011-0.

REASON: The plastic capacitor may overheat, posing a fire hazard in the unit.

CLASS III

MANUFACTURER: Abbott Diagnostics, Division of Abbott Laboratories, Abbott Park, Illinois.

PRODUCT: ARCHITECT LH Reagent Kit; a chemiluminescent microparticle immunoassay for quantitative determination of human leutenizing hormone in human serum and plasma for the prediction of ovulation, in the evaluation of infertility, and diagnosis of pituitary and gonadal disorders. Recall #Z-026-0.

REASON: Results generated with these lots may exhibit an over recovery.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 6, 1999:

UPDATE 

The following two recalls which appeared in the October 6, 1999 Enforcement Report were re-classified from Class II to Class III recalls and should read as follows: 

1)  MANUFACTURER Inovision Radiation Measurements, Cleveland, Ohio. RECALLED BY Manufacturer, by letters on July 8, 1999, and September 10, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 89 units. 

PRODUCT Model 35040 Keithley Therapy Dosimeter, intended use for calibration of dosimetry of therapeutic radiation treatment machine for high-energy accelerators, cobalt 60, and brachytherapy equipment. Recall #Z-1261-9. CODE Serial Numbers: 69450-69469; 80276-80295; 82666-82685; 81909-81928; and 86087-86106. 

REASON A 1.6 Amp fuse may have been installed where a 1 Amp is specified.

2)  MANUFACTURER Inovision Radiation Measurements, Cleveland, Ohio. RECALLED BY Manufacturer, by letters on July 8, 1999, and September 10, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 40 units. 

PRODUCT. The Tracker Display Model #35360A is sold with the Detector Model #35300A and marketed together as the Keithley Model #90100 Tracker System, a radiation measurement system intended for use in quality asurance programs for high energy accelerators, and cobalt 60 machines. Recall #Z-1262-9. CODE Serial Numbers: 83728-83747 and 84582-84601.

REASON A 1.6 Amp fuse may have been installed where a 1 Amp is specified.

CLASS II

MANUFACTURER: VF-Works, Inc., Palm Harbor, Florida.

PRODUCT: Visualizer 2000 Diagnostic X-Ray System. Recall #Z-1242-9

REASON: All units are in noncompliance with 21 CFR 1020.32(b) (2) because the collimator was not properly designed to provide necessary x-ray field limitation. In addition, 25 of the units manufactured on or before July 29, 1997, are also in noncompliance with 21 CFR 1020.32(h) because they were not equipped with a five-minute cumulative timer.

MANUFACTURER: Villa Sistemi Medicali S.p.A.

PRODUCT: Aztech 70 X-Ray System, intended for use in dental radiography. Recall #Z-1254-9

REASON: The diagnostic x-ray devices were found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications on equipment manufactured before September 1, 1999.

MANUFACTURER: Codman - A Johnson & Johnson Company, Norton, Massachusetts.

PRODUCT: Codman Surgical Patties (size 1/2 x 1/2 inch), sterile, indicated use is protection of tissue, including brain and other tissues of the central nervous system, during surgery. Recall #Z-1260-9.

REASON: Surgical Patties incorrectly assembled without a radiopaque marker and string.

MANUFACTURER: Inovision Radiation Measurements, Cleveland, Ohio.

PRODUCT: Model 35040 Keithley Therapy Dosimeter, intended use for calibration of dosimetry of therapeutic radiation treatment machine for high energy accelerators, cobalt 60, and brachytherapy equipment. Recall #Z-1261-9

REASON: An incorrect fuse was installed on units causing power failures from flown fuse.

MANUFACTURER: Inovision Radiation Measurements, Cleveland, Ohio.

PRODUCT: The Tracker Display Model #35360A is sold with the Detector Model #35300A and marketed together as the Keithley Model #90100 Tracker System, a radiation measurement system intended for use in quality assurance programs for high energy accelerators, and cobalt 60 machines. Recall #Z-1262-9

REASON: An incorrect fuse was installed on units causing power failures from blown fuse.

CLASS III

MANUFACTURER: Sunrise Mobility Products Division, Kid Kart Operations, Belgrade, Montana.

PRODUCT: The Kid Kart 19-Inch Lap Belts, a component of mechanical chair with casters. Recall #Z-1239-9

REASON: The lap belts were assembled incorrectly.

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

PRODUCT: Port-A-CATH Implantable Access System, designed to permit repeated access to the vascular system for the parenteral delivery of medications, nutritional solutions, and other fluids and for the sampling of venous blood. Recall #Z-1259-9.

REASON: Product equipped with an incorrect size catheter introducer component. The recalled lot contain size 6 French introducers rather than the specified size 8.5 French introducers.

MEDICAL DEVICE SAFETY ALERT

PRODUCT Olympic Mini Bili-Lite, Model 70 and 71. Safety Alert #N-010/011-9 CODE Catalog Numbers: 51470 and 51471. 

MANUFACTURER Burton Medical Products, Chatsworthy, California. ALERTED BY Olympic Medical Corporation, Seattle, Washington, by fax during the week of September 7, 199. DISTRIBUTION Nationwide and international. QUANTITY 314 

REASON Interior casting in Bili-Lites may fracture causing light to fall. 

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

CLASS II

MANUFACTURER: Boston Scientific Corporation Northwest, Redmond, Washington.

PRODUCT: Rotabulator Rotalink, indicated for use in patients with coronary artery disease: a) Rotablator RotaLink Plus Pre-connected Exchangeable Rotational Atherectomy System with Catalog Nos. 23631-002, 23621-003, 23631-004, 23631-004, 23631-006, 23631-007, 23631-015, 23631-016; b) Rotablator RotaLink Coronary Advancer with Catalog Nos. 22782-001A0, 22782-0010; c) Rotablator RotaLink Peripheral Advancer with Catalog No. 11281-90, intended for percutaneous transluminal angioplasty.

REASON: The braking mechanism may fail to secure the guidewire during use, which can cause the guidewire to move suddenly, resulting in vessel damage.

CLASS III

MANUFACTURER: Shirakawa Olympus Company, Ltd., Japan.

PRODUCT: EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center, an endoscopic video imaging system that provides photo/video documentation of the upper lower gastrointestinal tract using the EVIS 140 series video endoscopes.

REASON: The device has a malfunction due to incorrect coding of the software, which can cause the software to overwrite the patient ID number with any comments that are entered by the user. 

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

CLASS II

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

PRODUCT: Percutaneous Sheath Introducer Kit, Catalog #AK-09903-S. Recall #Z-1226-9.

REASON: The dilator may not pass over the 0.035" spring wire guide.

MANUFACTURER: Picker International, Inc., Highland Heights, Ohio.

PRODUCT: ACQPLAN, Radiation Therapy Planning System, a software option for the Computed Tomography (CT) Scanners. Recall #Z-1236-9.

REASON: An incorrect calculation of Iso/N dosage may result when changing parameters.

MANUFACTURER: GE-YMS, Ltd., Hino-Shi, Tokyo, Japan

PRODUCT: CT Lemage/Prospeed and CT Legato/Sytec Sri Computed Tomography Scanners. Recall #Z-1240/1241-9.

REASON: The table cradle stopped moving and the system continued to emit radiation, resulting in the patients being exposed to X-rays at the same time location for more than one scan.

UPDATES 

MINI Digital Hanging Scale, Model 1200 (Integrated Measurement Systems, Inc.), Recall #Z-1237-9 which appeared in the September 8, 1999 Enforcement Report should read: CODE: All serial numbers.

 Tracheostomy Care Trays (Sterling Disposable Products), Recall #Z-1232/1235-9 which appeared in the September 8, 1999 Enforcement Report should read: CODE: Catalog #4118, 4120 4125, 4128, RW031. Lot numbers: a) standard tray, 24 per case: Catalog #4118, lots RJ0028, RJ0030, RJ0031, SC1522, SD1523, SD1524, SE1525; also reorder #RW031, lots RJ0036, RJ0038, SC1635, SD1644; b) Deluxe Tray, w/extra towel and pipe cleaners, 24 per case: Catalog #4120, lots RJ0026, RJ0034, SC1526, SD1528, SD1655, SE1527, SE1529, RP0105, RP0108; c) Standard Tray w/forceps and CSR Wrap, 20 per case: Catalog #4125, lot SD1575; d) Standard Tray w/Hydrogen Peroxide, 20 per case: Catalog # 4128, lots RJ0021, RJ0022.

CLASS III

MANUFACTURER: Advance Medical Designs, Inc., Marietta, Georgia.

PRODUCT: Sterile Bag Decanter, Part #10-102. Recall #Z-1230-9.

REASON: The devices would fall apart due to inadequate gluing of components.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 8, 1999:

CLASS II

MANUFACTURER: Howmediea Osteonies, Allandale, NJ

PRODUCT: Passport Recessed Patella Reamer Shaft. Recall # Z-1231-9.

REASON: Case slippage of the reamer stop component which results in removal of to much material from the patella. 

MANUFACTURER: Integrated Measurement Systems, Inc., Elk Grove Village, IL.

PRODUCT: Model 1200 Mini Digital Hanging Scale. Recall # Z-1237-9

REASON: The scale may disconnect from the lifter boom.

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

PRODUCT: Hemodialysers. Recall # Z-1238-9.

REASON: Crack blood ports, which may compromise the sterility barrier and cause leakage.

MANUFACTURER: Sterling Disposable Products, Inc.

PRODUCT: Tracheostomy Care Trays. Recall # Z-1232/1235-9.

REASON: Trays were contaminated with ETO resistant mold.

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

CLASS II

MANUFACTURER: Precision Therapy International, Inc., Norcross, GA

PRODUCT: 3-D Imgcomp Utility User Manual Update, Recall # Z-1223-9

REASON: A design error may lead to a serious miscalculation of radiation dose.

MANUFACTURER: ACUMED, Inc., Beaverton, OR.

PRODUCT: Mimi-Acutack 1.5 mm Cannulated Hex Driver Tip, Part #HAD-L-0815. Recall #Z-1225-9.

REASON: The Hex driver tips may prevent the Mini-Acutrak Bone Screw from seating properly.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA

PRODUCT: CryoValve (Heart valve), Recall # Z-1228/1229-9

REASON: Does not meet current guidelines regarding serodilution of plasma.

CLASS III

MANUFACTURER: KAVO DENTAL GmBH, Biberach-Riss, Germany

PRODUCT: STRAUMANN INTRAsurg 500, an AC powered drilling device intended to supply power to and serve as a base for other dental devices such as a dental handpiece during dental and maxillofacial surgery, Recall # Z-1215-9.

REASON: Software error may cause unit to shutdown prior to reaching preset torque limit.

MANUFACTURER: ORGANOGENESIS INC. , Canton, MA

PRODUCT: APLIGRAF (GRAFTSKIN), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not responded to conventional therapy. Recall #Z-1219-9

REASON: Products ph may be out of specification due to packaging error.

The following is a condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 25, 1999

CLASS II

MANUFACTURER: Quinton Instrument Company, Bothell, Washington.

PRODUCT: AngioCOMM Workstation (previously StatVIEW) 1. AngioCOMM Review Station reviews and analyzes angiographic injection image sequences acquired by the Network Interface Station or by downloading DICOM studies from a CD-ROM: a) AngioCOMM Single Sequence Review Station b) AngioCOMM Mobile Review Station 2. AngioCOMM Network Interface Station (NIS) provides the capability to capture, review, and archive coronary injection sequence images from an x-ray system in the cath lab: c) AngioCOMM Single Sequence Network Interface Station, Pentium Pro d) AngioCOMM Single Sequence NIS Pentium. Recall #Z-1116/1119-9.

REASON: Under certain specific circumstances, sequences of a single plane study may overlap sequences of bi-plane study when viewing both on the AngioCOMM Single Sequence Review Station or the Single Sequence Network Interface Station (NIS).

MANUFACTURER: Atlanta Thermoplastics, Tucker, Georgia.

PRODUCT: Light Handle Covers, single use cover for OR light handles to maintain sterility during OR procedures, sold in single and multi-packs and as a component in surgical trays. Recall #Z-1146-9.

REASON: Surgical device cover on handle may come off and compromise sterility during surgery.

MANUFACTURER: Scanac of Sweden acquired in 1998 by Warner Electric, AB, Partille, Sweden.

PRODUCT: Hoyer Power Lifter Actuators, a 12 volt DC electromechanical device marketed as a component of several patient lifting devices, part of a retrofit kit for unpowered patient lifting devices or as a stand alone component. a) Model No. 59105, Retro-fit Power Conversion Kit b) Model No. 53005, Power Partner Lifter c) Model No. 53006, Power Partner Stand-Assist Hoyer Lifter d) Model No. P-C-HLA, Power Chrome Litter e) Model No. 400-2543 - Assigned to kit that includes the motor/ballscrew assembly, the battery charger and the hand control f) Model No. 400-2546 - assigned to the motor/ballscrew assembly (Actuator only) g) Model No. 400-2384, Replacement Battery Pack. Recall #Z-1147/1153-9.

REASON: A short circuit in the system will cause the batteries to discharge, resulting in the generation of heat which may cause fire, fumes, smoke or loss of power.

MANUFACTURER: Trex Medical Corporation, Copaigue, New York.

PRODUCT: Bennett Contour2, Stereotactic Ready Mammography Machine, an x-ray device. Recall #Z-1209-9.

REASON: The subtray mandrels (pins) used to attach the mammography Bucky tray or the optional Cytoguide to the vertical C-Arm of the mammography machine can, overtime, become loose or bend and break.

MANUFACTURER: Organigenesis, Inc., Canton, Massachusetts.

PRODUCT: Apligraft (Graftskin), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not adequately responded to conventional Recall #Z-1210-9.

REASON: Burkholderia cepacia contamination.

MANUFACTURER: Institut Sraumann AG, Waldenbrug, Switzerland.

PRODUCT: ITI Extender System Octa Abutment (also referred to as the Bone Graft Octa Abutment, H 2.1 mm) a component of the ITI Extender System. Recall #Z-1211-9.

REASON: Potential for abutment to fracture due to error on the tolerance value for the depth of the hole on the modified engineering drawing.

MANUFACTURER: Mallinckrodt, Inc., Irvine, California.

PRODUCT: Shiley Adult Tracheostomy Tubes, intended for use in providing tracheal access for airway management: a) Catalog Nos. DCT, DFEN, DCFS, DCFN, & PERC b) Catalog Nos. LPC, FEN, CFN, CFS, & LGT. Recall #Z-1213/1214-9.

REASON: The lug pin, which hold the soft swivel flange to the cannula may break, causing displacement of the flange.

MANUFACTURER: Beckman Coulter, Carlsbad, California.

PRODUCT: Synchron Systems Digoxin Reagent, Catalog No. 650182, used in conjunction with the SYNCHRON Systems Drug Calibrator 2 set and is intended for the quantitative determination of total digoxin concentration in human serum or plasma on SYNCHRON CX Systems. Recall #Z-1216-9.

REASON: The devices may produce false low digoxin results.

MANUFACTURER: New York Organ Donor Network (NYODN), New York, New York.

PRODUCT: Heart Valve Harvested from a cadaveric donor. Recall #Z-1217-9.

REASON: The specimen collected from donor was found to be repeatedly reactive for HbsAg.

MANUFACTURER: Seamed Corporation, Redmond, Washington.

PRODUCT: Sorin Blood Cardioplegia Console, Model BCC-02, Part #R DP48-0001-102, designed for use during cardiopulmonary bypass procedures to control the introduction of blood and crystaloid delivery in the management of cardioplegia delivery. Recall #Z-1218-9.

REASON: The device may deliver the blood/cardioplegia solution at uncontrolled high speed (overspeed pump condition).

UPDATE 

CPI Endotak DSP Implantable Leads, Recall #Z-1144/1145-9 which appeared in the August 18, 1999 Enforcement Report should read: QUANTITY: 29,500 leads.

CLASS III

MANUFACTURER: Pfizer Hospital Products Group, Howmedics, Inc. Rutherford, New Jersey.

PRODUCT: Omega Plus Compression Hip Screw System with Varies Product Codes from a - t Recall #Z-1182/1201-9.

REASON: The inner dimension of the sideplate had dimensions that were too small, resulting in the sideplate not sliding fully into the lag screw.

MANUFACTURER: Howmedica Osteonics Corporation, Allendale, New Jersey.

PRODUCT: Series 7000 Total Knee Modular Tibial Tray, a component of the Total Knee System, implanted into a patient along with other knee system components as part of a knee replacement. Recall #Z-1202-9.

REASON: The Tibial Tray labeled as Catalog No. 7376-0005 was laser etched with the wrong Catalog No. 7115-0005.

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia.

PRODUCT: Cryovalve Allograft (Heart Valve). Recall #Z-1203-9.

REASON: Additional information for the organ procurement agency concerning this donor revealed that the donor possessed genital Condylomata (genital warts).

MANUFACTURER: The Binding Site, Ltd., Birmingham, England.

PRODUCT: Human Beta-2 Microglobulin Kits, products are in-vitro diagnostic kits and an antiserum: a) Product Code No. LK043.B, Human Beta-2 Microglobulin Behring Nephelometric Analyzer (BNA) Kit b) Product Code No. LK043.BH, Elevated Level Human Beta-2 Microglobulin Enhanced Nephelometric BNA Kit c) Product Code No. CUS1303, Human Beta-2 Microglobulin Enhanced Nephelometric BNA Kit d) Product Code No. LA043.B, Human Beta-2 Microglobulin Latex Enhanced Antisera BNA e) Product Code No. LK043.C, Human Beta-2 Microglobulin Turbidometric Roche Cobas Mira (MIRA) Kit. Recall #Z-1204/1208-9.

REASON: We are classifying the firm's action as a voluntary recall. We consider the devices to be adulterated in that they may give falsely elevated levels with urine samples.

MANUFACTURER: Abbott Laboratories, Abbott Park, Illinois.

PRODUCT: Architect Free T3 Reagent Kit, a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma. Recall #Z-1212-9.

REASON: Low recovery when used with multi-constituent controls.

MANUFACTURER: KAVO DENTAL GmBH, Biberach-Riss, Germany.

PRODUCT: KaVo Intrasept 905, INTRAsurg 500 Dental Operative Unit, an AC powered drilling device intended to supply power to and serve as a base for other dental devices such as a dental handpiece during dental and maxillofacial surgery. Recall #Z-1215-9.

REASON: Software defect may cause the unit to shutdown prior to reaching the preset torque limit.

MANUFACTURER: Organogenesis, Inc., Canton, Massachusetts.

PRODUCT: Apligraf (Graftskin), indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficiency of greater than 1-month duration which has not responded to conventional therapy. Recall #Z-1219-9.

REASON: The pH was found to be out of specification range.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 18, 1999:

CLASS II

MANUFACTURER: SAFFETA, Inc., Safety Harbor, Florida.

PRODUCT: Various First Aid Kits containing the suspect Povidone-Iodine Pads labeled in part: several SAWYER PRODUCTS FIRST AID KITS with several product numbers.

REASON: The kits may contain non-sterile Povidone Iodine pads.

MANUFACTURER: Mallinckrodt Nellcor Puritan Bennett (MNPB), Carlsbad, California.

PRODUCT: MNPB Ventilator and Graphic User Interface (GUI), CPU Board and Breath Delivery Unit (BDU), CPU Board Assemblies Model #840, a dual-microprocessor electronic system for use to provide precise breath delivery for critically ill infant pediatric, and adult patients. Recall #Z-1142-9.

REASON: The voltage regulator may manifest by not allowing control changes to be passed from the GUI onto the BDU and/or overheating with resultant heat or smoke.

MANUFACTURER: NMJ SA de CV (Mallinckrodt Medical), Juarez, Mexico.

PRODUCT: Intermediate Hi-Lo Pre-Cut Tracheal Tube with Stylet, for airway management by oral intubation of the trachea.

REASON: The incorrect stylet was used and is too long, extending beyond the tip of the tube.

MANUFACTURER: Guidant Corporation, St. Paul, Minnesota.

PRODUCT: CPI Endotak DSP Implantable Leads: a) Model 0095; b) Model 0125. Recall #Z-1144/1145-9.

REASON: The lead is bent sharply away from the header block, the integrity of the lead and/or lead insulation can be compromised.

MANUFACTURER: Alcon Laboratories, Houston, Texas.

PRODUCT: Alcon Surgical Procedure Packs Custom Pak: a) Product #4345-12; b)6899-03. Recall #Z-1161/1162-9.

REASON: Light handle covers did not fit properly onto the light handle. Further, the poor fit might cause the light handle cover to be too loose which might result in the cover falling off the handle in the sterile field or cause the cover to be too tight which might result in the cover splitting during use.

MANUFACTURER: Intermedics, Inc., doing business as Guidant Intermedics, Angleton, Texas.

PRODUCT: Intermedics single and dual-chamber pulse generators., several model numbers. Recall #Z-1163/1181-9.

REASON: The pulse generators were shipped from the factory with a pulse amplitude that did not match the inquired nominal value as reported by the programmer.

CLASS III

MANUFACTURER: Arthrex Arthroscopy Instruments, Inc., Naples, Florida.

PRODUCT: Bio-Interference Screw, 8mm size. Recall #Z-1113-9.

REASON: Screws may crack during insertion.

MANUFACTURER: Depuy Acromed, Raynham, Massachusetts.

PRODUCT: Pedicle Screw is a component of the VSP Spinal Fixation System. Recall #Z-1114-9.

REASON: The device was incorrectly labeled 6.25 mm diameter/titanium vs. actual product 7.0 mm stainless.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 11, 1999:

CLASS II

MANUFACTURER: F. Walter Hanel GMBH DBA MAVIG, Munich, Germany

PRODUCT: Medrad Counterpoise System Product Number 75-4000-033. Recall #Z-957-9.

REASON: Dowel pins used in support assembly have potential to back out of position.

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

PRODUCT: Screwdriver Blade - Self-Retaining: a) Part 313.922; b) Part 313.923. Recall #Z-958/959-9.

REASON: The inspection technique used to inspect the blades had the potential to miss some non-conforming blades. In addition, a tolerance issue was noted between screwdrivers with blades on the lower end of the spec and screw slots on the upper end of the spec.

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

PRODUCT: Holding Sleeve Part #314.06. Recall #Z-960-9.

REASON: An operation for crimping the back end of the sleeve was not on the process sheet or specifications for the product.

MANUFACTURER: Synthes (USA), Monument, Colorado,

PRODUCT: Wire Tensioner, Part #393.742. Recall #Z-963-9.

REASON: The wire tensioner may or may not accept a 2.0 mm guide wire.

MANUFACTURER: Nellcor Puritan Bennett, Inc., Mervue, Galway, Ireland.

PRODUCT: NPB-190 and NPB-195 Pulse Oximeter, Rx, intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate for use on adult, pediatric, and neonatal patients in hospital and home environments. Recall #Z-1154/1155-9.

REASON: The devices fail to alarm when a pulse oximetery sensor became disconnected from the patient.

MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, Utah.

PRODUCT: Uro-View X-Ray Imaging Systems: a) Model 2600; b) Model 2500; c) Model 2000. Recall #Z-1156/1158-9.

REASON: The leg extension can become disengaged and cause a patient to slide to the floor.

UPDATE

Millennium VG Neuclear Medicine Scanner and Varicam Neuclear Medicine Scanner, Recall #Z-745/747-9 which appeared in the April 7, 1999 Enforcement Report should read: CODE: Millennium VG or Varicam Systems with serial numbers below 10000 (ten thousand) except for the following list: 1001, 1756, 1839, 1840, 1890, 1891, 3010, 5008.

CLASS III

MANUFACTURER: Synthes (USA), Monument, Colorado

PRODUCT: 1.3 mm Box Plate: a) Part #421.095; b) Part #421.096. Recall #Z-961/962-9.

REASON: Plates were switched during processing resulting in a 5x10 mm box plated labeled as a 10x10 mm box plate and vice versa. 5x10 mm is part #421.095 and 10x10 mm is part #421.096.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: 7.0 mm Cannulated Screw, 32 mm Thread, 70 mm Length. Recall #Z-964-9.

REASON: Package is labeled as 7.0 mm cannulated screw, 32 mm thread, 70mm length. Package actually contains a 7.0 mm cannulated screw, 16 mm thread, 70 mm length.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Synthes (USA) Midfacial System. Recall #Z-965-9.

REASON: The device was anodized gold instead of greengray.

MANUFACTURER: Synthes (USA), Monument, Colorado.

PRODUCT: Extraction Bolts for 3.5/4.0 screws. Recall #Z-966-9.

REASON: Extraction bolts were misetched with 6.5/7.0 instead of 3.5/4.0

MANUFACTURER: Waters Instruments, Inc., Rochester, Minnesota.

PRODUCT: MOX-100 DCM Disposable Organ Preservation Cassette, a sterile, single use, receptacle for transporting kidneys to be used as implanted organs. Recall #Z-1112-9.

REASON: The device sometimes leaks perfusate, a solution used to nourish and chill kidneys, causing a drop in the perfusate level.

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

PRODUCT: Outer Cannula for the Ci/C2 Drill Guide. Recall #Z-1115-9.

REASON: The cannula disengaged from the handle assembly at the solder joint. The solder joint may not be adequate enough to hold the two components together.

MANUFACTURER: Synthes (USA) West Chester Pennsylvania.

PRODUCT: Screw/Post for Distractors: a) Part #U44-640-12; b) Part #U44-640-16 Recall #Z-1159/1160-9.

REASON: The pin contains features on the back end which prevent it from being inserted into the mating handle.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 4, 1999:

CLASS II

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

PRODUCT: Marquette Clinical Information Center Software. The Clinical Information Center displays data from up to 16 patient monitors. Recall #Z-917-9

REASON: Defective software could result in failure to give warning.

MANUFACTURER: Alcon Puerto Rico, Inc., Humacao, Puerto Rico.

PRODUCT: a) Viscoat Viscoelastic Solution, 0.5 ml, Catalog Number 8065-1839-05 PMA P840064; b) Duovisc Viscoelastic System, 0.5 ml, Catalog Number 8065-1831-05. Recall #Z-1088/1089-9

REASON: Product was distributed without the cannula locking ring.

MANUFACTURER: Ansell, Inc., Dothan, Alabama.

PRODUCT: Lifestyles & Contempo Assorted Colors Lubricated Condoms model: Contempo Intensity Assorted Colors Condoms Product Code 4535 & 4560; Lifestyles Assorted Colors Lubricated Product Code 5303/605149. Recall #Z-1049/1050-9.

REASON: Holes were discovered in condoms during a routine monitoring by the State of North Carolina.

MANUFACTURER: Spacelabs Burdick, Inc. Deerfield, Wisconsin.

PRODUCT: Eclipse LE II Electrocardiograph, Model 92304. Recall #Z-1097-9.

REASON: The ground wire of the device could fail, due to "over-crimping".

MANUFACTURER: Paragon Healthcare Corporation, Spartanburg, South Carolina (reprocessor).

PRODUCT: Orthogonal Electrophysiology Catheters: a) Fixed, 6 French (F); b) Deflectable, 7F; c) Deflectable, 6F; d) Deflectable, 8F; e) Mansfield Fixed, 6F, Catalogue No. 5211. Recall #Z-1105/1109-9.

REASON: An electrode may separate from the catheter, while it is being separated from a patient.

MANUFACTURER: Medtronic, Inc., Neurological Division, Minneapolis.

PRODUCT: a) Medtronic DBS Lead Kits for Deep Brain Stimulation, Model Nos. 3382, 3387, 3387RES, and 3389; b) Medtronic Customer Engineered Burr Hole Cap and Ring, Model Nos. 3350SP and 3350SPJ. Recall #Z-1110/1111-9

REASON: There are visible chemical residues on some of the Burr Hole Caps through which the leads are inserted.

CLASS III

MANUFACTURER: Surgidyne, Inc., Plymouth, Minnesota.

PRODUCT: Surgidyne VariDyne Vacuum Controller and Collection System, Model 350-2id, a portable powered aspiration pump used for closed wound, surgical sump, nasogastric and other tube drainage. Recall #Z-948-9

REASON: The devices had incorrect graphics plate.
 

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