The Food and Drug Administration has ordered Baxter International Inc. to recall 200,000 of the company’s Colleague brand pumps, escalating its scrutiny of infusion pumps used primarily in hospitals to deliver fluids to patients. The FDA said the Deerfield, Ill.-based drug and device maker must “recall and destroy” all of its Colleague pumps, saying the action was based on “a long-standing failure” of the company to correct serious problems with them. The FDA said infusion pumps, including Baxter’s Colleague, had caused “persistent safety problems.” In the last five years, the FDA has received more than 56,000 reports of adverse events that included serious injuries and more than 500 deaths. The medical product giant said it worked with the FDA to minimize disruption to hospitals using the Colleague pumps. The company will be offering healthcare facilities the opportunity to exchange the pumps without charge.Baxter will offer to exchange its Sigma Spectrum infusion pumps for the Colleague brand.

 

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