The FDA today issued 2 recall notices related to CareFusion‘s Alaris pumps, including 1 to CareFusion over alarm issues and another to Elite Biomedical Solutions over a flaw in a replacement frame membrane for the drug pumps.
The FDA has labeled the recalls as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
CareFusion received 108 reports of an error in which a visual and audible alarm that causes the Alaris pump to stop supplying infusion to the patient, according to the FDA.
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