FDA Warns Baxter Over Dialysis Systems

Law360, New York (June 30, 2010, 1:27 PM EDT) -- The U.S. Food and Drug Administration has issued a warning to medical device maker Baxter Healthcare Corp. over an alleged failure to report problems with its dialysis systems.

Baxter failed to report several serious incidents with its HomeChoice peritoneal dialysis systems within the required 30 days, the FDA said in a June 3 letter that was publicized Tuesday. Some of the complaints showed the devices may have contributed to serious injuries, the FDA said.

The FDA's warning stems from an inspection of Baxter's McGaw Park, Ill.,...
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