Urgent Recall Issued for Baxter Electronic Infusion Pumps

Risk of Injury or Death Resulting from Software and Battery Usage Failures

Following a notice sent out by Baxter Healthcare Corporation regarding problems with its Triple Channel Volumetric Infusion Pumps, the FDA has issued a Class I recall of the products. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. Baxter has identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.

The pumps involved in this recall are Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps, 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.

MARCH-12-09: Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps [FDA: BAXTER ELECTRONIC INFUSION PUMPS RECALLED]

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Published on Mar-12-09