May 5, 2014 — The U.S. Food and Drug Administration (FDA) is warning that the Acclaim infusion pump, sold by Hospira Inc. and Abbott Laboratories, have a defective door that may cause over-infusion or a delay in infusion therapy. Using this product could result in serious patient injury or death.
Normally, when the door is closed properly, it helps ensure that the tubing is seated properly so the patient receives the appropriate flow of infusion therapy. According to the Class 1 recall notification, the Acclaim infusion pump was recalled because:
“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 recall affects products with list numbers 12032 and 12237. They recalled Abbott infusion pumps were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004. The recalled Hospira infusion pumps were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.
Hospira estimates that the life expectancy of the door is five years. They recommend inspecting the door handle for cracks before programming an infusion therapy. They have provided a guide for customers.
Infusion pumps are used for controlled delivery of fluid medicines, blood, blood products, nutritional fluids, and other medical treatments into a patient’s body. They are intended for use in hospitals, ambulances, nursing homes, or home care.
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