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CareFusion hit with Class I notice for pump recall

This article was originally published in Clinica

Executive Summary

CareFusion’s recall of 17,000 Alaris PC intravenous pumps has been given a Class I notification from the US FDA. CareFusion noticed that the pumps could suffer a communication error under certain wireless conditions and sent an urgent recall notice to its customers on 24 August. The error may result in a delay of therapy and an inability to make programming changes to the current infusion settings. This, in turn, could lead to adverse health consequences or death. CareFusion (San Diego, California) is conducting a field corrective action to update the hardware on the affected units which were manufactured or serviced between December 2008 and September 2009. The firm has recorded a reserve charge in its 2010 fiscal fourth quarter for all the actions related to the corrective action plan.

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