FDA IV pump update


Intravenous news: The FDA report “Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter’s long-term failure to correct serious problems with Colleague pumps.

Baxter is required to give Colleague pump owners a cash refund or a replacement pump at no charge. Also, facilities that lease Colleague pumps may terminate the lease without penalty. The company must also give a full refund for unused Colleague pump spare parts, batteries, and consumables.

The company’s Transition Guide will give details on the refund or replacement program, provide a list of alternative pumps, and offer suggestions to help minimize disruption and patient risks during the transition period. The Guide will be issued no later than September 11, 2010.

Baxter’s guide will also describe how to fill out a Certificate of Medical Necessity. It is important to submit this certificate by November 14, 2010 in order to receive a replacement or refund, and so that Baxter can continue to provide service and maintenance for existing units.”

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