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U.S. Department of Health and Human Services

Safety

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Alaris System (Cardinal Health)

Audience: Hospital risk managers

[Posted 08/05/2009] FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Health’s Alaris System, electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. The firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. It was determined that the five failures  may result in patients experiencing under- or over-infusion which may result in serious injury or death.The device is intended for use with adult and pediatric patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices, and nursing homes. 

[08/05/2009 - Class 1 Recall - FDA]