FDA Issues Class 1 Recall for Hospira GemStar Infusion for Battery Malfunction

An FDA Class 1 recall has been issued for Hospira’s GemStar Infusion System, a device for use in intravenous, arterial, subcutaneous, short-term infusion and parenteral administration of general IV fluids and medications, according to the American Society of Anesthesiologists.

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FDA recalls Hospira GemStar Infusion SystemThe problem stems from the lithium battery voltage, which can drop below 2.4 volts and interrupt the device’s operations. The battery malfunction can also erase infusion settings and event history logs.

All lithium batteries older than three years should be replaced, according to the release. For more information, check with the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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