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U.S. Department of Health and Human Services

Safety

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Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter

Audience: Hospital administrators, hospital risk managers, healthcare professionals
[Posted 03/12/2009] FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

[March 11, 2009 - Recall Notice - FDA]