July 23, 2007

FDA ALERT

FDA - MedWatch - Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream.

The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. There are reports of serious injuries that are associated with this issue. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death. Remove all the affected triple channel pumps from service immediately.

COLLEAGUE customers with questions should contact Baxter Medical >Delivery Services at 1-800-843-7867.

Read the complete MedWatch 2007 safety summary, including a link to the
manufacturer's Recall notice regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#BaxterInfusion