U.S. warns Baxter over device marketing

Tue Oct 20, 2009 3:50pm EDT

* Company says letter refers to Isolex cancer device

* Company says working to address FDA concerns

WASHINGTON, Oct 20 (Reuters) - Baxter International Inc (BAX.N) is working to address complaints from U.S. regulators about the marketing of a device used in cancer therapy, the company said on Tuesday.

The Food and Drug Administration released a Sept. 10 letter warning Baxter that the label for one of its medical devices was false and misleading and the company's production of the product failed to comply with federal manufacturing standards.

The letter referred to Baxter's Isolex device used in cancer therapy, according to Baxter spokeswoman Mavis Prall. The version of the letter the FDA released to the public did not identify the device.

Prall said Baxter had corrected one of the issues the FDA raised in its letter and "we continue to work with the FDA to address other issues."

Baxter is committed "to providing safe and effective quality products and services to our customers and to patients," she added.

Annual sales for Isolex total about $1 million, making the product a "tiny fraction of Baxter's overall business," Prall said.

The FDA posted the letter here. (Reporting by Lisa Richwine, editing by Carol Bishopric)





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