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Alaris infusion pump recall

This article was originally published in The Gray Sheet

Executive Summary

CareFusion, which will soon spin off from parent firm Cardinal Health, is updating the software and directions for use for certain Alaris infusion pumps in a June 12 voluntary recall that FDA classified on Aug. 5 as Class I, the most serious category. Cardinal Health/CareFusion received 510(k) clearance for the software update in July and will provide it to customers within 60 days. Devices may have problems with pump warning messages, protection circuitry or components of the pumping mechanism that could lead to improper infusion therapy. In June, users were given risk mitigation steps to avoid overdosing until the software update arrives. CareFusion is setting aside $18 million for the corrective action, which could take a year to complete. Alaris pumps are currently subject to an FDA consent decree for manufacturing violations (1"The Gray Sheet" Feb. 23, 2009)

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