The FDA sent a letter to Baxter Healthcare Corp on April 30 ordering the company to recall and destroy all of its Colleague volumetric infusion pumps currently in use in the United States. The FDA based this action on a longstanding failure of the company to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 pumps currently in use.
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.
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.
For complete information read the FDA notice.