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Showing 62981–63000 of 68218 results

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Cook, Inc.: Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter i...

Packaging Problem: The peel-away sheath does not peel uniformly or completely.

FDADec 7, 2007Nationwide• Cook, Inc.

Medline Industries Inc: 1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor ...

Separation from Bushing: The breathing bag may separate from the bushing during use.

FDADec 7, 2007Nationwide• Medline Industries Inc

Cook, Inc.: Cook TPN Double Lumen Catheter set; Catheter introducer, ...

Packaging Problem: The peel-away sheath does not peel uniformly or completely.

FDADec 7, 2007Nationwide• Cook, Inc.

Cook, Inc.: Peel-Away Introducer set, 7.0 FR; Catheter introducer, in...

Packaging Problem: The peel-away sheath does not peel uniformly or completely.

FDADec 7, 2007Nationwide• Cook, Inc.

Medline Industries Inc: 3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor P...

Separation from Bushing: The breathing bag may separate from the bushing during use.

FDADec 7, 2007Nationwide• Medline Industries Inc

Cook, Inc.: Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer...

Packaging Problem: The peel-away sheath does not peel uniformly or completely.

FDADec 7, 2007Nationwide• Cook, Inc.

Siemens Medical Solutions USA, Inc.: syngo US Workplace Picture Archiving and Communication Sy...

Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

FDADec 6, 2007IN, NJ• Siemens Medical Solutions USA, Inc.

Ventlab Corporation: Ventlab-assembled Anesthesia breathing bags. The recall i...

During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.

FDADec 5, 2007IL• Ventlab Corporation

Edwards Lifesciences, Llc: Edwards LifeStent FlexStar Biliary Stent System; Biliary ...

Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.

FDADec 5, 2007Nationwide• Edwards Lifesciences, Llc

Biosite Inc: Triage Micro ClostrIdium difficile (C.difficile) Panel, C...

False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

FDADec 4, 2007Nationwide• Biosite Inc

Roche Diagnostics Corp.: Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Num...

Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.

FDADec 4, 2007IN, NE• Roche Diagnostics Corp.

Rockwell Medical Technologies, Inc: RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78...

Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

FDADec 3, 2007Nationwide• Rockwell Medical Technologies, Inc

Roche Diagnostics Corp.: Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 0...

False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.

FDADec 3, 2007Nationwide• Roche Diagnostics Corp.

Medtronic Neuromodulation: Medtronic Bravo pH Capsule with Delivery System, Stomach ...

Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

FDADec 3, 2007AL, AK, AZ +48 more• Medtronic Neuromodulation

Rockwell Medical Technologies, Inc: Glacial Acidic Acid (liquid component of Dri-Sate Dry Ac...

Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

FDADec 3, 2007Nationwide• Rockwell Medical Technologies, Inc

Fresenius Medical Care North America: Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No...

Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.

FDADec 3, 2007Nationwide• Fresenius Medical Care North America

Rockwell Medical Technologies, Inc: Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sat...

Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

FDADec 3, 2007Nationwide• Rockwell Medical Technologies, Inc

Siemens Medical Solutions USA, Inc: Siemens Magnetom Harmony syngo. Model Number: 7106714, Si...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Magnetom Sonata syngo, Model Number: 7106425, Sie...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Magnetom Harmony sygno. Model Number: 7104693, Si...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

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