Important Health Alert: FDA Recall of Baxter Healthcare’s Colleague Infusion Pumps

On April 30th the U.S. Food and Drug Administration released a letter to Baxter Healthcare Corp ordering a recall of the company’s Colleague Volumetric Infusion Pumps. Infusion pumps are machines that are used to deliver fluids, such as medications, into patients at regular controlled intervals. Within the last five years the FDA has received over 56,000 reports of grievous consequences resulting from the use of infusion pumps which includes serious injuries and more than 500 deaths. Baxter Healthcare Corp has been working to correct numerous flaws in the safety of the devices since 1999 and the FDA issued the first injunction on the manufacturing of the product in 2006. Although Baxter has made several changes in the device since that time, the FDA feels that the pumps are still too unsafe to be used on patients. On April 8th, Baxter proposed a correction schedule that would leave patients with unsafe pumps until 2013 and therefore the FDA found the correction schedule to be unacceptable. The FDA has ordered Baxter to “Recall and destroy all Colleague infusion pumps. Reimburse customers for the value of the recalled device. [And] Assist in finding a replacement for these customers,” as listed in a recent FDA press release on the subject.

Baxter’s infusion pumps are just one brand of unsafe pumps and the FDA will hold a public workshop in May on infusion pump design and to raise public awareness of safety issues with the pumps.

Scott Levensten, Esquire, of the Levensten Law Firm, has successfully represented injured victims of defective medical devices for nearly 15 years. If you would like Mr. Levensten to represent you or a loved one for injuries caused by a defective Colleague Infusion Pump, please contact us through this site, or you may email Mr. Levensten at sdl@levenstenlawfirm.com, or call the firm’s toll free number (800)-510-1325.