The latest defect identified with Baxter International Inc.’s problem-prone Colleague Volumetric infusion pump has been classified by the Food and Drug Administration (“FDA”) as a “Class 1 recall.” A Class 1 recall is the FDA’s most serious recall designation and is only issued “in a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The Baxter Colleague Volumetric infusion pump recall includes all Colleague Volumetric infusion pumps (single and triple channel) manufactured between February 1997 and December 2008 containing one of the following model numbers:

  • Mono 2M8151
  • Mono 2M8153
  • CX 2M8161
  • CX 2M8163
  • CXE 2M9161
  • CXE 2M9163

Although the recalled Colleague Volumetric infusion pumps, which are used to deliver intravenous fluids and medicine to patients, are not actually being taken off the market, the FDA says the serious warning is necessary because the defective products are so widely used and are potentially fatal.

Colleague Infusion Pump Inadequate Infusion

In a January 2009 letter, Baxter warned customers that failure codes in its Colleague Volumetric infusion pumps could cause them to shut down while delivering fluids, resulting in inadequate infusion. The company also cautioned that the infusion pumps could overheat and potentially catch fire. According to Baxter, safe and effective use of the Colleague Volumetric infusion pump depends on proper battery care practices.

Due to alarm failures, battery problems, software glitches and other defects, Baxter Colleague infusion pumps have not been sold in the United States since 2005. That year, a worldwide Colleague Volumetric infusion pump recall was initiated after Baxter received six reports of serious injury and three reports of death associated with a shut-down problem that resulted in colleague infusion pump inadequate infusion. Although Baxter has attempted to repair and upgrade the defective infusion pumps, problems have continued to occur with the replacements.

Baxter Colleague Volumetric Infusion Pump Recall Lawyer

If you or a family member were injured by a recalled Baxter Colleague Volumetric infusion pump, you may be entitled to compensation for your injuries. Contact a Colleague infusion pump injury lawyer today for a free and confidential case evaluation.

Published November 17, 2011 by