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Mandatory recall for Baxter pumps

This article was originally published in The Silver Sheet

Executive Summary

FDA ordered Baxter on April 30 to recall all Colleague infusion pumps on the U.S. market and destroy the devices due to, in the agency's words, "a longstanding failure to correct many serious problems." The agency instructed Baxter to reimburse customers for the value of the pumps or provide replacements at no cost. Baxter said May 3 that initial costs of removing the roughly 200,000 pumps will run as high as $600 million. The firm plans to replace the Colleague pumps with Sigma Spectrum infusion pumps. The recall stems from a June 2006 consent decree with FDA related to the Colleague pumps. Colleague has been the subject of several recalls in the past decade for "battery swelling, inadvertent power-off, service-data errors and other issues," FDA notes in a May 3 statement. Those problems culminated in the 2006 decree that barred new sales of Colleague and Syndeo infusion pumps until the issues were resolved, but the agreement also gave FDA the authority to take further regulatory action. Baxter made numerous changes to Colleague pumps in recent years, but FDA said the company's latest series of fixes - which Baxter said would correct all known issues with the devices - was inadequate

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