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FDA Class 1 Recall for GemStar Infusion Pump Docking Station

FDA Class 1 Recall for GemStar Infusion Pump Docking Station

May 2, 2014 — The U.S. Food and Drug Administration (FDA) and Hospira Inc. have issued a Class I recall for the GemStar Docking Station. When it is used with the GemStar Phase 3 infusion pump, the pump may fail to power up when connected to the docking station. The FDA has deemed this recall a Class I, which is the most serious type of recall.

The recall announcement states:

“If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003. If a GemStar fails to power up or the 11/003 error code stops an infusion, a delay of therapy may occur. A delay or interruption in therapy has a worst case potential to result in significant injury or death.”

Hospira does not recommend returning the docking station for repair. Instead, the FDA asks healthcare professionals to consider the risks and benefits of using the device, and consider using alternative devices when treating patients who might be severely injured or killed if an infusion is interrupted.

GemStar Infusion Pump Recall

Last November, Hospira issued a Class I recall for the GemStar Infusion Pump due to the risk of over-infusion or under-infusion. The problem was a defective pressure sensor that could cause electronic errors. Affected models include pumps manufactured after January 1, 2009 and those with a replaced pressure sensor.

What Products Were Recalled?

Impacted/ Affected Product CodeIssuePotential to Occur in Conjunction with Products (Description)Potential to Occur in Conjunction with List Numbers
13075Fail to Power UpGemStar Phase 3 pumps13000, 13100, 13150
Error Code 11/003GemStar Phase 3 pumps or GemStar Phase 4 pumps13000, 13100, 13150 13086, 13087, 13088

Do I have a Hospira GemStar Infusion Pump Lawsuit?

The Schmidt Firm, PLLC is currently accepting Hospira GemStar Docking Station induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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