Medical products company Baxter International will have to complete recall and replacement of as many as 200,000 defective infusion pumps by July 14, 2012, according to a final order issued by the U.S. Food and Drug Administration.
The action is aimed at protecting patients and removing the defective Colleague brand infusion pumps from the market. The FDA has been documenting a variety of flaws, including battery failures, power shortages and service-data errors, in the pumps since 1999. Baxter was ordered to stop manufacturing and distributing the pumps in 2006.
Under the agreement, Baxter will provide a transition guide to assist customers with replacing their infusion pumps, which are used in clinical and home-care settings to deliver fluids. The guide will provide a list of FDA-approved pump alternatives that can serve as replacements, and Baxter will also provide assistance to minimize care disruption to patients during the transition. The medical products company will also be responsible for the cost of refunding or replacing the defective pumps, or terminating leases without cost to patients, according to an FDA news release.