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FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

The FDA recently warned healthcare professionals of a recall of Plum A+ and Plum A+3 Infusion Systems by Hospira. These devices are used to deliver fluids, including "critical intravenous medication... into a patient's body in controlled amounts." Hospira has recalled infusion pumps manufactures and distributed between July 2012 and May 2014. The reason for the recall is faulty alarms that may fail to go off when an infusion therapy is interrupted. This alarm volume failure could lead to "prolonged interruption in therapy", which in turn could result in harm to the patient, with "the possibility of serious patient injury or death."

On behalf of Hospira, Stericycle Inc. has sent two Urgent Medical Device Correction letters with safety instructions to customers. Several safety organizations have also been notified of the recall. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty devices] will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436932.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm436770.htm

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