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U.S. Department of Health and Human Services

Safety

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Baxter Colleague Infusion Pumps: FDA Ordering Recall

Audience: Hospital Risk Managers

[UPDATED 12/01/2010] Recall classified as Class I. Recall initiated August 4, 2010, and includes all Colleague single channel, triple channel infusion pumps.

[Posted 05/04/2010] FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. 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. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

[11/30/2010 - Recall Notice - FDA]
[05/03/2010 - News Release - FDA]
[05/05/2010 - Q&A's - FDA]

Previous MedWatch Alert:

[03/12/2009]