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FDA Puts its Highest Risk Warning on Hospira, Abbott Infusion Pump Recall

May 7, 2014

The U.S. Food and Drug Administration (FDA) has categorized a recall of infusion pumps by Hospira and Abbott as Class I highest-risk, meaning that exposure to these devices can lead to serious injury or death. The recall, which was initiation last October, affects the Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps, List Numbers 12032 and 12237.

The recalled Abbott infusion pumps were manufactured from February 1998 to November 1998 and were distributed from September 1998 through February 2004. The recalled Hospira pumps were manufactured from February 1997 to February 2010 and distributed from July 1999 to November 2013. They are used to deliver parenteral infusions, including medicines and nutritional fluids.

According to the FDA notice, the recall was initiated because Hospira received reports that the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps had broken door assemblies. The agency stated that “When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the pump cannot be used which can result in a delay of therapy.” Using these recalled pumps “may cause serious adverse health consequences, including death” the notice said.

Hospira said that users should inspect the infusion pumps for door handle cracks before programming a therapy. Customers were told to check that the door is fully closed after inserting the tubing and closing the handle against the infusion pump; a door is not closed properly if a gap or separation exists. If the door is closed correctly, users should then “check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.” The company states that if free flow is detected, customers should close the roller clamp and remove the pump from clinical service. All potential users of the products should be aware of the recall and recommended actions, Hospira said.

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