CareFusion recall classified as most serious type
CHICAGO (Reuters) - The Food and Drug Administration has classified CareFusion Corp's August recall of 17,000 Alaris medication pumps as a Class I recall, the most serious type, the company said on Friday.
A Class I recall is a situation in which there is a reasonable probability that the product will cause serious health consequences or death.
CareFusion said it is working to correct the problem by updating hardware on the pumps and has recorded a reserve in its fiscal fourth quarter to complete remediation.
On August 24, CareFusion recalled the Alaris PC model 8015 manufactured or serviced between December 2008 and September 2009. It said the pump could experience intermittent communication errors under certain wireless network conditions, freezing the pump's screen and possibly delaying therapy.
If the communication error occurs during infusion, infusion continues as originally programed but cannot be modified. When this occurs, stopping infusion to make any modification or programing changes causes the pump to shut down, with a delay in therapy, which could lead to serious injury or death, the company said.
Such pumps are used to infuse medication into a patient's circulatory system.
CareFusion said the recall will have no effect on its infusion pump production or shipping processes.
(Reporting by Debra Sherman; editing by John Wallace)
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