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Class I Recall Issued for GemStar Infusion Pump

Class I Recall Issued for GemStar Infusion Pump

November 6, 2014 — The FDA has issued a recall for the GemStar Infusion Pump after receiving 20 complaints about a faulty power supply that could potentially catch on fire.

The power supply may fail to deliver electricity or overheat, which could interrupt infusion therapy unless there is a backup power supply.

Hospira notified customers of the problem in February, including specific instructions to avoid dropping, wiggling, or arcing the power supply to avoid damaging internal components. Of the 20 incident reports submitted to Hospira, one involved a power supply that overheated and smoked.

According to the FDA Class I recall notification:

“The use of the recalled devices may cause 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.”

An electrical spark from a malfunctioning pump could also spark a fire in oxygen-rich environments.

About 13,002 units were distributed worldwide, with 5,687 of those sold in the United States. The recall affects the Wall Mount Power Supply (list number 13026-05) and Desk Top Power Supply (list number 13072-05) manufactured and sold from October 2011 through April 2013. Click here for a list of recalled products.

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