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Quality / Medical Devices / Postmarket Safety / Commercial Operations

Hospira Hit With Another GemStar Infusion Pump Recall

Nov. 7, 2014

Hospira is recalling all of its GemStar Power Supply 3VDC units, used to power the GemStar Infusion Pump, because they may fail to deliver electric power to the pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used, according to a recall notice posted to the FDA’s website on Wednesday.

The FDA designated the recall a Class I, its most serious. The devices may cause serious health risks, including 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, the notice says.

The Lake Forest, Ill., devicemaker initially sent an “Urgent Medical Device Recall” letter to its customers on Feb 3. The recall includes all 13,002 units distributed worldwide, with 5,687 of those distributed in the U.S. The affected devices were manufactured from October 2011 and March 2013, and distributed between November 2011 and April 2013, the recall notice says.

Hospira received a total of 20 reported incidents including one report of smoke. The company found that the GemStar Infusion Pump was operating on battery power while still connected to the 3VDC power supply. There were no reports of injuries or death, the notice said.

Customers are advised to remove affected product from service if it’s believed the power supply is damaged for any reason. Hospira said there is no need to return fully functional power supplies.

This is the fifth time in three years Hospira has faced a GemStar-related recall. The pumps are used to deliver controlled amounts of fluids such as medicines, blood, blood products, nutritional foods and other mixtures into a patient.

View the recall notice at http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm421946.htm. — Kellen Owings

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