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Showing 19261–19280 of 22584 results

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Ethicon Endo-Surgery Inc: Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 ...

There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

FDAApr 20, 2006Nationwide• Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc: Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft...

There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

FDAApr 20, 2006Nationwide• Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc: Endopath Probe Plus II, Hand-Controlled PistolGrip Handle...

There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

FDAApr 20, 2006Nationwide• Ethicon Endo-Surgery Inc

Cook Endoscopy: Cook Esophageal Dilator Set -----------------------------...

Large product label contains an incorrect expiration date.

FDAApr 20, 2006AL• Cook Endoscopy

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. ...

Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm...

Due to potential embrittlement of the plastic tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: Duraflo Treated Aortic Perfusion Cannula with plastic tip...

Due to potential embrittlement of the plastic tip which may crack or separate during use.

FDAApr 18, 2006CA, CT, FL +7 more• Edwards Lifesciences Research Medical, Inc.

Electric Mobility Corp: Rascal 600F and 600T scooters, unspecified power wheelchair.

The four seat mast mounting screws can loosen, causing seat to wobble. The chair seat actuator and portions of the seat can malfunction and/or break. Firm is aware of problems with the seat and injuries sustained from the powered wheelchair/scooter seat malfunction. Firm has not initiated recall, claims it is a Warranty Advisory.

FDAApr 17, 2006Nationwide• Electric Mobility Corp

Beckman Coulter Inc: Coulter LH500 Hematology Analyzer: Part Numbers 178832, 1...

Beckman has confirmed that erroneous results could be reported when the workstation database crashes.

FDAApr 17, 2006Nationwide• Beckman Coulter Inc

Abbott Laboratories: CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath System...

High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

FDAApr 17, 2006AL, AR, CA +38 more• Abbott Laboratories

St. Jude Medical Daig Division: St. Jude AGILIS Steerable Introducer, Reorder number 4083...

St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.

FDAApr 14, 2006AL, AK, AZ +33 more• St. Jude Medical Daig Division

Bausch & Lomb: Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose sof...

Reports of Fusarium Infections among contact lens wearers.

FDAApr 13, 2006Nationwide• Bausch & Lomb

Teleflex Medical: Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, ex...

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

FDAApr 12, 2006Nationwide• Teleflex Medical

Eagle Vision Inc: Valve-EV Glaucoma Ultra-Smooth, P/N 6006

Product may have deformed valves which would cause the valve not to operate properly.

FDAApr 12, 2006Nationwide• Eagle Vision Inc

Eagle Vision Inc: Krupin Eye Valve, P/N 6003

Product may have deformed valves which would cause the valve not to operate properly.

FDAApr 12, 2006Nationwide• Eagle Vision Inc

Intuitive Surgical, Inc.: Intuitive brand Da Vinci S Surgical System, an Endoscopic...

Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.

FDAApr 12, 2006Nationwide• Intuitive Surgical, Inc.

Eagle Vision Inc: Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V

Product may have deformed valves which would cause the valve not to operate properly.

FDAApr 12, 2006Nationwide• Eagle Vision Inc

Teleflex Medical: Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium ...

The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

FDAApr 12, 2006Nationwide• Teleflex Medical

Roche Diagnostics Corp.: Roche/Hitachi Glucose Hexokinase Reagent for use on the ...

A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.

FDAApr 12, 2006Nationwide• Roche Diagnostics Corp.

Smith & Nephew Inc: Genesis II, Cruciate Retaining, Oxinium, Femoral componen...

Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.

FDAApr 12, 2006IN, LA, NC• Smith & Nephew Inc

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