The U.S. Food and Drug Administration (FDA) has placed its most serious recall status on a recall of infusion pumps by Hospira and Abbott. The agency has designated the recall as Class I; class I recalls are placed on products that have the potential to cause serious injury or death. The Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps, List Numbers 12032 and 12237 were initially recalled last October due to reports of broken door assemblies.
According to the FDA recall notice, the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps are being recalled due to broken door assemblies. “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.” the notice reads. The agency also states that using these products “may cause serious adverse health consequences, including death”.
Customers affected by the recall were given specific instructions about how to handle the products. Hospira said that users should inspect the infusion pumps for door handle cracks before programming a therapy, and check that the door is fully closed after inserting the tubing and closing the handle against the infusion pump. The door is only closed properly when no gap or separation exists. Doors that do not close properly should be removed from clinical service and customers should call Hospira, the notice states. 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.
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 distributed from July 1999 to November 2013 and manufactured from February 1997 to February 2010. The infusion pumps are used to deliver parenteral infusions and enteral fluids, including medicines and nutritional fluids.