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Showing 66601–66620 of 68218 results

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Zimmer Orthopaedic Surgical Products: Zimmer Orthopaedic Surgical Products, Disposable Cuff, 4...

The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

FDAOct 27, 2004Nationwide• Zimmer Orthopaedic Surgical Products

Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085: V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket...

The dispenser box was mislabeled with the wrong length and the wrong wire gauge.

FDAOct 27, 2004MS, MO, NY +4 more• Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085

Stryker Howmedica Osteonics Corp.: The Triathlon Posteriorly Stabilized Femoral Component.

The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.

FDAOct 27, 2004Nationwide• Stryker Howmedica Osteonics Corp.

Trinity Biotech USA: AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T99...

Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

FDAOct 27, 2004Nationwide• Trinity Biotech USA

Gillette Research Institute: Oral- B CrossAction Power Toothbrush , Soft (Battery Ope...

Brushhead may unlatch from the power handle

FDAOct 27, 2004Nationwide• Gillette Research Institute

Gillette Research Institute: Oral-B CrossAction PowerMAX Rechargeable Toothbrush, , So...

Brushhead may unlatch from the power handle

FDAOct 27, 2004Nationwide• Gillette Research Institute

Gillette Research Institute: CrossAction Power Brushead Refills, Soft 2-Count Pack ND...

Brushhead may unlatch from the power handle

FDAOct 27, 2004Nationwide• Gillette Research Institute

Abbott Health Products, Inc.: IMx HAVAB Controls are for In Vitro Diagnostic use. The k...

Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.

FDAOct 27, 2004AZ, CA, IL +10 more• Abbott Health Products, Inc.

Diasorin Inc.: Data reduction program written for a specific automated m...

Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

FDAOct 26, 2004CT, MI, MT +1 more• Diasorin Inc.

Beckman Coulter Inc: SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classifi...

Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.

FDAOct 25, 2004Nationwide• Beckman Coulter Inc

Gaymar Industries Inc: XPRT Therapy Mattress Systems: Model # 2950-000-000 with...

Design control/validation deficiencies.

FDAOct 25, 2004HI, IN, NE• Gaymar Industries Inc

Becton Dickinson & Company: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Nee...

Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

FDAOct 22, 2004AR, TX• Becton Dickinson & Company

Boston Scientific Corp: NAMIC Custom Angiographic Kit, Left Heart Kit. - . Mode...

The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

FDAOct 21, 2004IL, IN, NV• Boston Scientific Corp

ela Medical Llc: Alto implantable cardioverter defibrillator

Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.

FDAOct 21, 2004Nationwide• ela Medical Llc

Boston Scientific Corp: NAMIC Custom Angiographic Kit, Left Heart Kit - . Model...

The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

FDAOct 21, 2004IL, IN, NV• Boston Scientific Corp

General Electric Med Systems LLC: Patient tables of CT systems with brand name: CT/e; CT/e ...

The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.

FDAOct 21, 2004Nationwide• General Electric Med Systems LLC

BD Diagnostic Systems: BD, Brucella melitensis Antigen

Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

FDAOct 20, 2004Nationwide• BD Diagnostic Systems

BD Diagnostic Systems: BD, Salmonella O Group B Antigen (1-4-5-12)

Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

FDAOct 20, 2004Nationwide• BD Diagnostic Systems

BD Diagnostic Systems: BD, Salmonella O Group A Antigen (1-2-12)

Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

FDAOct 20, 2004Nationwide• BD Diagnostic Systems

BD Diagnostic Systems: BD, Proteus OX19 Antigen

Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

FDAOct 20, 2004Nationwide• BD Diagnostic Systems

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