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Showing 21641–21660 of 22584 results

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Boston Scientific Corp: Product in clear plastic pouch labeled: Boston Scientific...

Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.

FDAMar 18, 2004CA, CT, FL +8 more• Boston Scientific Corp

Toshiba American Med Sys Inc: Computed Tomography, Models TSX-101A and TSX-021A.

Erroneous patient data is entered. Previoius patient's demographics are recorded.

FDAMar 17, 2004Nationwide• Toshiba American Med Sys Inc

Zimmer Inc.: Zimmer brand Coonrad/Morrey total elbow interchangeable u...

Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.

FDAMar 16, 2004Nationwide• Zimmer Inc.

Zimmer Inc.: M/DN Intramedullary Fixation Humeral Nail

One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.

FDAMar 16, 2004Nationwide• Zimmer Inc.

Hill-Rom, Inc.: Hill-Rom brand TotalCare bed system; model P1900 -remanuf...

A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.

FDAMar 15, 2004AZ, FL, GA +4 more• Hill-Rom, Inc.

Steris Corp: QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Chan...

A defective port adapter may affect the sterilization process of the attached endoscope.

FDAMar 15, 2004CA, CT, IL +14 more• Steris Corp

Bayer Healthcare LLC 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291: Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C...

Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.

FDAMar 12, 2004Nationwide• Bayer Healthcare LLC 1884 Miles Ave Buildings 110 (Adlake), 17 & 18 Elkhart IN 46514-2291

Ciba Vision Corporation: FreshLook ColorBlends, Daily wear soft (hydrophilic) cont...

The lens inside the package does not match the prescription information labeled on the primary package.

FDAMar 11, 2004Nationwide• Ciba Vision Corporation

Codman & Shurtleff, Inc.: Codman Holter Salmon Rickham Reservoir with Ventricular C...

Drainage tips absent from catheter tip

FDAMar 11, 2004CA, GA, MI +4 more• Codman & Shurtleff, Inc.

Ciba Vision Corporation: FreshLook Colors, Daily wear soft (hydrophilic) contact l...

The lens inside the package does not match the prescription information labeled on the primary package.

FDAMar 11, 2004Nationwide• Ciba Vision Corporation

SCC Soft Computer: SoftPath GUI version 3.17.6.3.1. SCC Soft Computer 34350 ...

For clients using the SoftPath GUI version 3.17.6.3.1 Results Reporting interface with parsed text and having the auto correct and auto formatting functions active in MS Word, there is a possibility for some ANSI characters/symbols to be translated incorrectly to ASCII. SCC Soft Computer initiated a Correction in March 2004 for all affected clients.

FDAMar 11, 2004Nationwide• SCC Soft Computer

Ciba Vision Corporation: FreshLook Enhancers, Daily wear soft (hydrophilic) contac...

The lens inside the package does not match the prescription information labeled on the primary package.

FDAMar 11, 2004Nationwide• Ciba Vision Corporation

Guidant Corp-Cpi Division: Guidant Rapido 8 French Guiding Catheter, Inner Diameter ...

The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.

FDAMar 11, 2004Nationwide• Guidant Corp-Cpi Division

Ciba Vision Corporation: FreshLook Toric, Daily wear soft (hydrophilic) contact le...

The lens inside the package does not match the prescription information labeled on the primary package.

FDAMar 11, 2004Nationwide• Ciba Vision Corporation

Guidant Corp-Cpi Division: Guidant EasyTrak 8 French Guiding Catheter, Inner Diamete...

The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.

FDAMar 11, 2004Nationwide• Guidant Corp-Cpi Division

Baxter Healthcare Renal Div: Baxter Meridian Hemodialysis Instrument, product codes 5M...

Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.

FDAMar 10, 2004Nationwide• Baxter Healthcare Renal Div

Roche Diagnostics Corp.: AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX...

Marketed without PMA or 510(k) approval.

FDAMar 10, 2004FL, VA• Roche Diagnostics Corp.

Roche Diagnostics Corp.: AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MW...

Marketed without PMA or 510(k) approval.

FDAMar 10, 2004FL, VA• Roche Diagnostics Corp.

Becton Dickinson Infusion Therapy: BD L-Cath EX (28ga x 20cm), L-Cath Catheter System

Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

FDAMar 9, 2004Nationwide• Becton Dickinson Infusion Therapy

Diasorin Inc.: ELx800 microtiter plate reader software program written f...

An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.

FDAMar 9, 2004AL, AK, AZ +31 more• Diasorin Inc.

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