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FDA ISSUES RECALL NOTICE ABOUT GEMSTAR INFUSION PUMP POWER SUPPLY

FDA ISSUES RECALL NOTICE ABOUT GEMSTAR INFUSION PUMP POWER SUPPLY

The FDA recently warned healthcare professionals of a recall of Hospira's Wall Mount and Desk Top GemStar Power Supplies. These accessories provide power to the GemStar Infusion Pump, which is "used to deliver controlled amounts of fluids including medicines, blood, [and] nutritional foods... into a patient's body..." Hospira has recalled power supplies distributed between November 2011 and April 2013, noting that all units distributed in the U.S. and worldwide could fail. The reason for the recall is a defect that may cause improper delivery of electric power to the GemStar Infusion Pump. Such failure of the power supply could lead to "serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death."

Hospira has sent Urgent Medical Device Correction letter with safety instructions to its customers. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty] products will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm421951.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm421946.htm

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