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Infusion Pumps

Baxter Receives 510(k) Clearance From FDA For COLLEAGUE Infusion Pumps

Published in Medical Letter on the CDC and FDA, March 18th, 2007

Baxter Healthcare Corporation announced that it has received clearance from the U.S. Food and Drug Administration (FDA) on its COLLEAGUE infusion pump 510(k) pre-market notification. The company is preparing to modify pumps currently in the market and will soon submit manufacturing and service documentation to FDA in advance of deploying upgrades to U.S. COLLEAGUE infusion pumps. Baxter will continue to communicate and work directly with customers in the coming months to establish deployment schedules and begin remediation activities.

"Resolving issues with the COLLEAGUE infusion pump has been Baxter's top priority. We appreciate customers' continued support as we've...

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