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U.S. Department of Health and Human Services

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Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps 02/02/2006

Audience: Hospital nursing supervisory personnel and risk managers
[Posted 02/02/2006] Baxter Healthcare Corp. and FDA notified healthcare professionals of a Class 1 recall of all models of COLLEAGUE Volumetric Infusion Pumps, used to give controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural or other direct line into the bloodstream. Reasons for the recall include one or more of the following conditions: battery undercharging, false alarms/shutdown, gearbox wear, under-infusion, and/or non-detection of upstream occlusion. Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

[February 02, 2006 – Recall Notice – FDA]

Previous MedWatch Alerts:

[July 21, 2005]