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CareFusion Issues New Recall for Ventilators

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CareFusion has issued its second recall for ventilators, saying this is an urgent recall that involves problems that could lead to serious injury or death. According to CareFusion, it has recalled 29 of its EnVe ventilators over problems that could lead to delayed starts or shut down.

The recalled machines were manufactured between December 2010 and May 2011, said SignOn San Diego, noting that the U.S. Food and Drug Administration (FDA) assigned its most serious designation—Class I—to this recall. The FDA describes Class I recalls as involving situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.

CareFusion said it sent out the urgent notifications on September 12 to medical centers known to be using the defective devices, said SignOn San Diego. “CareFusion is conducting a field corrective action to update the hardware and software on affected ventilators,” it said. “The company determined the root cause for each issue and is committed to updating each device in a timely manner with minimal disruption to customers,” CareFusion added, reported SignOn San Diego.

SignOn San Diego pointed out that one year ago, the FDA designated a CareFusion recall of 17,000 electronic infusion pumps as a Class I, noting that the devices could undergo dangerous shut downs over wireless network connection issues. At the time of that recall, CareFusion promised that it would correct the units and provided customers with warning tags that were to be attached to the defective devices and instructions on how to disable the pump’s wireless connection, said SignOn Dan Diego.

The EnVe ventilator has three problems: A possible delay in ventilation resumption after the device has been reconnected, potential automatic reset, and potential disconnection if the device is moved, said SignOn San Diego, which noted that ventilator failure can cause an oxygen shortage in the patient.

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