Baxter Mislabeled Chemotherapy Device: FDA

Law360, New York (October 21, 2009, 3:45 PM EDT) -- Pharmaceutical and medical device maker Baxter International Inc. is working to address questions raised by the U.S. Food and Drug Administration over a device used in cancer treatments, the company said Wednesday.

On Tuesday, the FDA released a letter sent to Baxter on Sept. 10, in which the agency identified labeling and manufacturing issues related to one of the company's medical devices.

Baxter spokeswoman Mavis Prall said the letter referred to the company's Isolex device and the reagent kit used with the device. Isolex is used...
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