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FDA Issues Class I Recall of Hospira GemStar Infusion Pumps

Nov 27, 2013

Hospira Inc. has been forced to issue another recall of its GemStar Infusion Pumps because of associated defects capable of risking lives and causing serious injuries among those patients who rely on the device to continue living.

The U.S. Food and Drug Administration (FDA) this week deemed a recall issued earlier this year for Hospira’s GemStar Infusion System pumps as a Class I action. This designation indicates that regulators believe use of the recalled medical devices could endanger a patient's life or cause serious injuries with lifelong and life-altering consequences.

The recall is specific to Hospira GemStar Infusion System Model number 13000, 13100, 13150, 13086, 13087, and 13088.

According to a release from the FDA, removing these Hospira GemStar Infusion System pumps from the market was necessary because "the proximal and distal pressure sensor calibration can drift, resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual."

The recalled Hospira GemStar Infusion System pumps may also prompt the following errors during the setup of the device or amid an actual infusion treatment: Cassette Check-D, Cassette Check-P, Proximal Occlusion, Distal Occlusion, Pressure Calibration Error, Bad Pressure Sensor Event, Bad Pressure Sensor State, Distal Pressure is Out of Range, Proximal Sensor is Out of Range.

These errors could cause numerous problems with the Hospira GemStar Infusion System pumps. The defects could cause audible or visual warnings not to prompt, miss problems with an infusion treatment or even shut down during an infusion treatment. All these errors could cause patients relying on them to endure life-threatening circumstances, the FDA notes in its latest update on the recall.

Regulators urge medical professionals and patients to weigh the risks associated with these pumps before using them and to definitely consider an alternate means of delivering this therapy.

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