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See Latest ArticlesCardinal Health, FDA amend infusion pump consent decree
Cardinal Health, 02/18/09
Cardinal Health announced it has reached agreement with the Food and Drug Administration on an amended consent decree regarding the company's infusion pump products. Cardinal Health has operated under a consent decree since February 2007 for its Alaris SE pumps, which resulted in the company implementing a new quality system on April 2008. Under the amended agreement, which is subject to approval by the U.S. District Court for the Southern District of California, Cardinal Health will conduct a thorough review of its broader line of infusion pump products within 60 days and submit a corrective action plan to the FDA that outlines all planned modifications to any infusion pump products.
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