MASSDEVICE ON CALL — The FDA put their highest-risk warning on a recall of infusion pumps by Hospira (NYSE:HSP) and Abbott (NYSE:ABT), saying that a broken door assembly may cause an over- or under-infusion of drug therapy.
The FDA noted that Hospira had received customer complaints about the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. The devices are used to deliver a range of therapies, including whole blood, medicines and nutritional fluids.
The federal watchdog agency gave the recall a Class I label, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
"When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient," according to the FDA notice. "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 Abbott Acclaim manufactured from February 1998 to November 1998 and Hospira Acclaim Encore infusion pumps manufactured from February 1997 to February 2010, according to the FDA notice.
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