The Food & Drug Administration classified the recall of approximately 17,000 CareFusion Corp. (NYSE:CFN) Alaris PC infusion units as a Class I recall.
That’s the most serious level of product recalls for the federal watchdog agency, indicating a reasonable probability that the use of the recalled product "will cause serious adverse health consequences or death," according to the FDA.
The Alaris PC unit recall covers model 8015 that CareFusion manufactured or serviced between December 2008 and September 2009, according to the company.
San Diego-based CareFusion said it informed customers of the recall Aug. 24 in a letter to customers stating that "under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen." The failure could result in a delay of therapy to a patient and prevent caregivers from making programming changes to any current drug infusion, a situation that could cause serious injury or death. CareFusion posted information and instructions regarding the mitigation of the risk on its website.
The company recorded a reserve in its 2010 fiscal fourth quarter for expenses related to its plan to correct the device problems and said it believes the reserve amount will still cover the cost of the recall.