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On April 30th, the U.S. Food and Drug Administration (“FDA”) sent a letter to Baxter Healthcare Corp., directing the company to recall and destroy all of its Colleague Volumetric Infusion Pumps (a.k.a. Colleague Pumps) currently in use in the United States. This response comes after the company’s longstanding failure to correct serious defects with the pumps.

Infusion pumps are medical devices used to deliver fluids, such as nutrients and medications, into a patient’s body in a controlled manner. They are widely used in hospitals, clinical settings, and increasingly in the home where accuracy in fluid delivery is important. Despite the advantages that functional infusion pumps provide, the devices have a history of persistent safety problems. For example, the FDA has received more than 56,000 reports of adverse effects associated with the use of infusion pumps in the last five years. Between 2005 and 2009, eighty-seven infusion pump recalls were required to address safety concerns. Adverse effects ranged from software defects to user interface problems to mechanical and electrical failures.

According to the FDA, there are as many as 200,000 of these pumps currently in use. Device flaws in Baxter Colleague pumps have been documented since 1999. Since then, Colleague pumps have been recalled for battery swelling, inadvertent power off, service data errors, and other issues. The FDA obtained a consent decree of permanent injunction in June 2006, prohibiting Baxter from manufacturing and distributing all models of their Colleague pumps until the company corrected the manufacturing deficiencies. Although Baxter Healthcare Corp. put together a proposal to correct adulterated and misbranded pumps starting in May 2012, the FDA rejected the proposal for the overly lengthy timeframe.

Now, the FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device(s), and assist in finding a replacement for the affected customers. For more information on the recall, refund, and replacement of Baxter Colleague pumps, please review the FAQs posted by the FDA.

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