Class I Recall of Smiths Medical Medfusion Model 4000 Syringe Infusion Pump
Published: Aug 3, 2012
The U.S. Food and Drug Administration (FDA) are notifying healthcare professionals and medical care organizations of the Class I recall of all Model 4000 pumps with software Versions V1.0 and V1.1 due to system errors that can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, resulting in a delay or an interruption of patient therapy. Delay or interruption of infusion therapy could result in serious injury and/or death.
The Medfusion 4000 is a wireless, electronic infusion pump used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients. Affected pumps were distributed from September 10, 2010, to February 3, 2012.
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