GemStar Infusion System FDA class 1 recall due to lithium battery low voltage problem


Intravenous products: FDA report “Hospira notified healthcare professionals of a Class I recall of the GemStar Infusion System, Models 13000, 13100, 13150, 13086, 13087, 13088. When the GemStar Lithium battery voltage level drops below 2.4 volts, an “11/004″ error is displayed and the device is rendered inoperable. This failure mode results in a delay/interruption of therapy. Additionally, infusion settings and event history logs will be erased as a result of this device malfunction.

The severity of the clinical impact, due to the delay/interruption in therapy, is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay/interruption in therapy has a worst case potential to result in a significant injury or death.

The affected units were manufactured and distributed between February 1999 and April 2013.”

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