A Class 1 recall has been issued by the FDA for batteries in the GemStar infusion system made by medical device company Hospira (NYSE:HSP).
The federal watchdog agency issued the alert for all models of the GemStar infusion pump, intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products, according to the FDA.
Hospira issued a letter to customers March 18, warning that damage from battery leakage may cause the device to shut off without warning.
"The severity of the delay/interruption in therapy is dependent on the underlying condition of the patient and the treatment being prescribed," the company wrote. "A delay/interruption in therapy or under-infusion has a worst case potential to result in significant injury or death."
The company said healthcare professionals should consider use of an alternate pump in cases where any delay or under-infusion could result in injury or death and recommended checking the pump’s battery compartment should be inspected for signs of corrosion. Batteries older than 3 years should be replaced, Hospira said.
