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FDA Issues Statement on Baxter's Recall of Colleague Infusion Pumps
Date:5/3/2010

SILVER SPRING, Md., May 3 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration sent a letter to Baxter Healthcare Corp. on April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

Additionally, the FDA is ordering the company to provide refunds to customers or replace pumps at no cost to customers help defray the cost of replacement. 

Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

Hospitals and other users of Baxter's Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.

In

SOURCE U.S. Food and Drug Administration
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