Baxter Infusion Pump Recall

On May 3, 2010, Baxter Healthcare Corporation announced a recall of its Colleague volumetric infusion pumps, widely used in hospitals and other healthcare facilities to deliver medication and other fluids to patients. The defective pumps can fail to properly deliver the correct amount of medication to patients.

The Food and Drug Administration (FDA) has ordered Baxter to recall and destroy the pumps in the U.S., since the company has failed to correct serious problems that were identified back in June 2006.

According to Baxter spokeswoman Erin Gardiner, the recall affects an estimated 200,000 pumps used by healthcare professionals and consumers nationwide. The FDA is ordering Baxter to reimburse customers for the value of the pumps, as well as to help customers find an equivalent replacement. The company expects that the recall will cost between $400 million and $600 million in the first quarter.

In 2005, an estimated 7,000 Colleague pumps were seized by the FDA, after the agency received reports of 16 injuries and seven deaths from the pumps malfunctioning during use. In 2006, the company entered into a consent decree with the FDA concerning problems with the Colleague pumps and the Syndeo drug pump. Although several changes have been made to the Colleague pump since 2006, the FDA ordered a recall to ensure patients would not be treated with the inferior pumps.

 

Sources:

  1. http://www.baxter.com/press_room/press_releases/2010/05_03_10_colleague.html