FDA Issues Requirements for Baxter Infusion Pump Recall

Agency requiring Baxter to provide refunds or replacements or terminate leases
By Beth Gilbert
HealthDay Reporter

THURSDAY, July 15 (HealthDay News) -- The U.S. Food and Drug Administration has issued conditions for Baxter Healthcare Corporation to follow in performing its April 2010 recall of Colleague Volumetric Infusion Pumps (CVIPs), and the agency is requiring the company to provide refunds or replacement pumps for customers or terminate their leases.

In addition to recalling approximately 200,000 CVIPs currently being used in the United States, the FDA is requiring that Baxter provide customers affected by the recall with a transition guide that includes a list of FDA-approved or FDA-cleared pump alternatives; information on refunds, replacements, and lease terminations; and suggestions to aid in minimizing patient risks and disruptions.

Customers who submit a Certificate of Medical Necessity to Baxter will receive service, replacement batteries, and spare parts for the affected pumps during the transition period. The company will continue to support affected pumps for 24 months and will complete the recall and the replace or refund programs by July 14, 2012. The FDA has been working with Baxter since 1999 to correct a number of flaws in the CVIPs, which have been the subject of several recalls for issues including battery failure, service data errors, and inadvertent powering off.

"This action reflects the agency's commitment to protect patients by removing unsafe infusion pumps and to promote public health through assuring the availability of safe and effective alternatives," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

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