Baxter Healthcare Corp. in association with the FDA has recently issued a Class 1, worldwide recall of the COLLEAGUE® Volumetric Infusion Pumps manufactured and distributed between February 1997 and December 2008, because they can shut down while delivering critical medication and fluids to patients.

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Recall Issued on Baxter Electronic Infusion Pumps

-Medscape

03/12/2009 - A class 1 recall has been issued on Baxter Healthcare Corp Colleague Single and Triple Channel Volumetric Infusion Pumps manufactured and distributed between February 1997 and December 2008, the US Food and Drug Administration (FDA) says.

The recall pertains to model numbers Mono 2M8151, Mono 2M8153, CX 2M8161, CX 2M8163, CXE 2M9161, and CXE 2M9163.

"This action has been classified by FDA as a Class I recall because of the risk of serious injury or patient death if affected devices malfunction," note the pump manufacturers in a press release.

The recall letter, issued on January 23, 2009, states that software and battery usage failures could result in interruption of therapy, damaged battery messages, smoke and fire hazards, and serious injury and/or death.

The letter advises institutions to have contingency plans to verify that back-up pumps are available and provides instructions for addressing interruption of therapy resulting from any type of failure code and damaged battery messages. The letter also describes ways in which to properly clean the device to prevent overheating, which can result in smoke and fire.

Customers may call Baxter Healthcare Corp at 1-800-843-7867. The complete Urgent Device Correction letter is available at http://www.baxter.com/about_baxter/news_room/downloads/1-23-09_Final_US_Letter_2.pdf.

Electronic infusion pumps deliver controlled amounts of medications or other fluids through intravenous, intra-arterial, epidural, or other acceptable routes of administration.

Adverse events or quality problems associated with the use of these products should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

If you or a loved one suffered injuries or death from a recalled Baxter COLLEAGUE or Flo Guard Volumetric infusion pump you may be entitled to compensation. Contact the Baxter infusion pump attorneys of Ennis & Ennis, P.A. today by filling out our free case evaluation form on this page or by calling toll-free 1-800-856-6405. Our experienced lawyers can answer any questions you may have about the Baxter infusion pump recall and potential Baxter infusion pump class action lawsuit.

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