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Showing 19101–19120 of 22584 results

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Smith & Nephew, Inc. Endoscopy Division: Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Ge...

Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division: TriVex 100SV Resector Kit, 4.5 Part Number: 7205876

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

FDAJun 19, 2006Nationwide• Smith & Nephew, Inc. Endoscopy Division

Zimmer Inc.: Zimmer Trabecular Metal Shoulder Instrumentation Distal P...

During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.

FDAJun 16, 2006Nationwide• Zimmer Inc.

Teleflex Medical: Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short;...

Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user.

FDAJun 15, 2006Nationwide• Teleflex Medical

MRL, Inc., A Welch Allyn Company: Welch Allyn AED 20 Automated External Defibrillator; a po...

The Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

FDAJun 15, 2006Nationwide• MRL, Inc., A Welch Allyn Company

Stryker Spine: Stryker Reflex Hybrid Level Anterior Cervical Plate; Non ...

Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

FDAJun 14, 2006Nationwide• Stryker Spine

Invacare Corporation: Pronto M51 Wheelchair, component- seat

Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.

FDAJun 14, 2006Nationwide• Invacare Corporation

Biocare Systems Inc.: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, Bi...

Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard

FDAJun 14, 2006Nationwide• Biocare Systems Inc.

Stryker Spine: Stryker Reflex Hybrid variable self-drilling screw. Non S...

Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

FDAJun 14, 2006Nationwide• Stryker Spine

Boston Scientific Corp: Vaxcel Implantable Vascular Access System -Titanium Stand...

Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error)

FDAJun 13, 2006CA, MD, NY +2 more• Boston Scientific Corp

Pointe Scientific, Inc.: Auto HDL reagent, sold by Pointe Scientific; Catalog no. ...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: Liquid AutoHDL Cholesterol Reagent Set, Manufactured for ...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: AutoHDL Cholesterol Reagent Set for the quantitative dete...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: Auto HDL Cholesterol reagent in bottles of 320 ml and 100...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: AutoHDL Cholesterol R1 Reagent Set, a homogeneous method ...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: AutoHDL Cholesterol R2 Reagent Set, a homogeneous method ...

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

FDAJun 12, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diag...

The reagent may be contaminated with microorganisms.

FDAJun 9, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: Liquid Alkaline Phosphatase (R2) Reagent Set for the quan...

The reagent may be contaminated with microorganisms.

FDAJun 9, 2006Nationwide• Pointe Scientific, Inc.

Pointe Scientific, Inc.: Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Ca...

The reagent may be contaminated with microorganisms.

FDAJun 9, 2006Nationwide• Pointe Scientific, Inc.

Abbott Laboratories MPG: CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic fo...

The CA 15-3 Controls replicates out of range high resulting in invalid runs.

FDAJun 9, 2006PR• Abbott Laboratories MPG

1...954 955956957 958...1130

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