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Showing 64481–64500 of 68218 results

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Stryker Instruments Div. of Stryker Corporation: Stryker Navigation System Remote Planning Stations with D...

A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

FDASep 8, 2006Nationwide• Stryker Instruments Div. of Stryker Corporation

Stryker Instruments Div. of Stryker Corporation: Stryker Navigation System, Navigation Laptop System with ...

A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

FDASep 8, 2006Nationwide

• Stryker Instruments Div. of Stryker Corporation

Micrus Endovascular Corporation: Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog...

During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.

FDASep 8, 2006Nationwide• Micrus Endovascular Corporation

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1200 Chemistry System, Automated Clinical Chemistry...

Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.

FDASep 8, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Stryker Spine: Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catal...

DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.

FDASep 8, 2006Nationwide• Stryker Spine

Becton Dickinson & Company: BD Vacutainer Luer-Lok Access Device Holder with Pre-Atta...

Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.

FDASep 8, 2006Nationwide• Becton Dickinson & Company

Stryker Instruments Div. of Stryker Corporation: Stryker Navigation System Dell Model D800 laptop computer...

A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

FDASep 8, 2006Nationwide• Stryker Instruments Div. of Stryker Corporation

Hydrocision, Inc.: Hydrocision SpineJet XL MIS 30 degree Handpieces, for cut...

Distal tip may become detached from the device

FDASep 7, 2006Nationwide• Hydrocision, Inc.

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: Abbott AxSYM system FSH Master Calibrators (LN 7A60-30),...

Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: Architect FSH Calibrators (LN 6C24-01), for in vitro diag...

Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Hydrocision, Inc.: HydroCision SpineJet XL MIS 20 degree Handpieces, for cut...

Distal tip may become detached from the device

FDASep 7, 2006Nationwide• Hydrocision, Inc.

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Diagnostic Chemicals, Ltd.: Microalbumin Multi-Calibrator Set, in vitro diagnostic. ...

Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

FDASep 6, 2006Nationwide• Diagnostic Chemicals, Ltd.

Baxter Healthcare Renal Div: Meridian Hemodialysis Instrument, product code 5M5576 and...

The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.

FDASep 6, 2006Nationwide• Baxter Healthcare Renal Div

Unknown Manufacturer: VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # ...

VHS Plate and lag screw components did not assemble correctly intraoperatively.

FDASep 6, 2006Nationwide

Unknown Manufacturer: VHS Pediatric Plate (for hip screw system) Ref 200501, VH...

VHS Plate and lag screw components did not assemble correctly intraoperatively.

FDASep 6, 2006Nationwide

Siemens Medical Solutions USA, Inc: Sienet Magic View 300, picture archiving and communicatio...

Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

FDASep 5, 2006Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Sienet Sky, picture archiving and communications system. ...

Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

FDASep 5, 2006Nationwide• Siemens Medical Solutions USA, Inc

Biogenex Laboratories: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371...

Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.

FDASep 5, 2006TX• Biogenex Laboratories

Accumetrics Inc: VerifyNow P2Y12 Assay Device Kit, Part Number 85054

The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

FDASep 5, 2006Nationwide• Accumetrics Inc

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