FDA gives Baxter two years to remove infusion pumps from market
This article was originally published in The Silver Sheet
Executive Summary
Baxter has until July 14, 2012, to ensure that all Colleague infusion pumps on the U.S. market have been recalled and destroyed, and that customers have received a refund or a replacement pump, according to a final recall order from FDA. The mandatory recall was announced in May, but FDA and the firm released details of the refund and replacement program July 13. Baxter is removing as many as 200,000 infusion pumps from the domestic market, including about 50,000 triple-channel pumps and 150,000 single-channel pumps. The relatively rare FDA enforcement action stems from a June 2006 consent decree related to persistent safety problems with the devices ("The Silver Sheet" July 2006). Within the next two years, Baxter must replace Colleague infusion pumps with Sigma Spectrum pumps at no cost, or refund customers the lesser of the Colleague pump's depreciated value or the purchase price, according to the July 13 recall order