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Showing 89261–89280 of 92420 results

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The OR Group: Stryker Universal Imaging Extension (OEM) Catalog Number:...

Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb

FDANov 6, 2003Nationwide• The OR Group

Merit Medical Systems, Inc: UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm,...

Angiographic catheter tips may separate during use.

FDANov 5, 2003FL, MI, NY +4 more• Merit Medical Systems, Inc

Abbott Laboratories HPD/ADD/GPRD: Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests a...

Aspiration errors in the conjugate component due to microbial contamination of the conjugate.

FDANov 5, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Merit Medical Systems, Inc: UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiograph...

Angiographic catheter tips may separate during use.

FDANov 5, 2003FL, MI, NY +4 more• Merit Medical Systems, Inc

Cryolife Inc: CryoValve Pulmonary Valve & Conduct

CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.

FDANov 4, 2003IN, MO• Cryolife Inc

Arrow International Inc: Arrow A Port with Attachable Silicone Rubber Catheters/10...

The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

FDANov 4, 2003IN, OR, VA• Arrow International Inc

Arrow International Inc: Arrow Low Profile Port with Attachable Silicone Rubber Ca...

The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

FDANov 4, 2003IN, OR, VA• Arrow International Inc

Owens & Minor Distribution, Inc.: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Sur...

Counterfeit product is an unapproved medical device with associated potential health hazard.

FDANov 3, 2003Nationwide• Owens & Minor Distribution, Inc.

Remel, Inc.: Remel QC-Slide Gram Stain Control, Catalog #40142, packag...

Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area

FDANov 3, 2003CT, IN, MA +10 more• Remel, Inc.

Beckman Coulter Inc: DataLink 2000 Data Manager

Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.

FDANov 3, 2003Nationwide• Beckman Coulter Inc

Cardinal Health: Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synt...

Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.

FDANov 3, 2003Nationwide• Cardinal Health

Abbott Laboratories Diagnostic Div: AEROSET Phenobarbital, LN 1E08-01

Assay is imprecise.

FDANov 3, 2003Nationwide• Abbott Laboratories Diagnostic Div

Heraeus Kulzer Inc.: Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); cat...

Packaging defects could result in improper mixing ratios and unusable impressions.

FDANov 1, 2003Nationwide• Heraeus Kulzer Inc.

McKesson General Medical Corporation: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Sur...

Counterfeit product is an unapproved medical device with associated potential health hazard.

FDAOct 31, 2003IN• McKesson General Medical Corporation

Beckman Coulter Inc: ICON 25 hCG Test Kit

False negative urine results are being observed at an increasing rate.

FDAOct 31, 2003Nationwide• Beckman Coulter Inc

Varian Brachytherary Virginia: BrachyVision software, catalog #AL15521003, CD-ROM (set o...

The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.

FDAOct 31, 2003Nationwide• Varian Brachytherary Virginia

Medtronic Surgical Navigation Tech, Inc: Fix pins associated with Stealth Station Treatment Guidan...

Surgical devices intended for single use were not labeled for single use.

FDAOct 31, 2003CA, FL, GA +3 more• Medtronic Surgical Navigation Tech, Inc

Maximus Medical Products Inc: 100 inch (254 cm) 15 Drop Administration Set with FlowSaf...

Mislabeled with wrong drop size drip chamber specification.

FDAOct 30, 2003CO, PA• Maximus Medical Products Inc

Q-Med Corporation: Product is a surgical device packaged in a box which is l...

This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.

FDAOct 30, 2003IL, IN, VA• Q-Med Corporation

Baxter Healthcare Corp. Rt: CA Cellulose Acetate High Efficiency Hollow Fiber Dialyze...

Use of the dialyzers may cause iritis (red-eye) patient reactions.

FDAOct 30, 2003Nationwide• Baxter Healthcare Corp. Rt

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