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Showing 64661–64680 of 68218 results

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AGFA Corp.: IMPAX 4.5 Systems, used in the acceptance, transfer, disp...

Possible corrupted image appearing after System Start.

FDAJun 30, 2006NY• AGFA Corp.

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1 Roller Pump 6 inch dia...

The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.

FDAJun 30, 2006Nationwide• Terumo Cardiovascular Systems Corp

A & E Industries, Ltd. Shenghui, South Road, Nantou Town, Zhong Shan City Guangdong China: Guardian Walker, Models 30751W, 30757W, 30758W, Made in C...

Walker wheel hubs may fracture, causing walker to collapse to one side.

FDAJun 30, 2006Nationwide• A & E Industries, Ltd. Shenghui, South Road, Nantou Town, Zhong Shan City Guangdong China

INO Therapeutics, Inc.: INOvent, Nitric Oxide Delivery System. Model Number 1605...

The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.

FDAJun 29, 2006Nationwide• INO Therapeutics, Inc.

Radiometer America Inc: SafeClinitubes, Capillary caps (purple), 905-787. The de...

Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.

FDAJun 29, 2006Nationwide• Radiometer America Inc

AGFA Corp.: CR DX-S, Image Intensified Fluoroscopic X-ray system.

Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

FDAJun 28, 2006CA, FL, MI +4 more• AGFA Corp.

ArthroCare Corporation: OPUS SpeedStitch Suture Cartridge with Magnumwire, a comp...

The product may lose sterility due to omission of the final pouch seal.

FDAJun 28, 2006Nationwide• ArthroCare Corporation

Roche Diagnostics Corp.: Accu-Chek Comfort Curve blood glucose test strips; (packa...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Invacare Corporation: Solara 2G manual wheelchair.

Laceration Risk

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

FDAJun 27, 2006Nationwide• Invacare Corporation

Roche Diagnostics Corp.: Accu-Chek Advantage II blood glucose test strips; Interna...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Accu-Chek Advantage Pro blood glucose test strips; Inter...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Accu-Chek Advantage blood glucose test strips; U.S. Refer...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Accu-Chek Sensor Comfort Pro blood glucose test strips; I...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Invacare Corporation: Solara Spree GT manual wheelchair.

Laceration Risk

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

FDAJun 27, 2006Nationwide• Invacare Corporation

Roche Diagnostics Corp.: Accu-Chek Advantage Plus blood glucose test strips; Inte...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Hardy Media Inc Dba Hardy Diag: BHI Agar with Vancomycin, for in vitro diagnostic use. C...

This recall is being conducted due to the performance failure nearing the end of the product shelf life.

FDAJun 27, 2006Nationwide• Hardy Media Inc Dba Hardy Diag

Roche Diagnostics Corp.: Accu-Chek Inform blood glucose test strips; International...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Accu-Chek Sensor Comfort blood glucose test strips; Inter...

The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results

FDAJun 27, 2006Nationwide• Roche Diagnostics Corp.

Enpath Medical, Inc.: Channel Steerable Sheath in 8F Enpath part # 10775-003, B...

Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.

FDAJun 27, 2006CA, MA• Enpath Medical, Inc.

Invacare Corporation: Solara Spree XT (SPRXT) manual wheelchair.

Laceration Risk

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

FDAJun 27, 2006Nationwide• Invacare Corporation

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