CareFusion Issues Class 1 Recall for EnVe Ventilators

CareFusion has issued a recall for 29 of its EnVe ventilators because of several problems that could delay the start of the machine or cause it to shut down. The U.S. Food & Drug Administration (FDA) has deemed the <"">CareFusion EnVe ventiltor recall Class 1, its most serious recall action, which indicates the recalled ventilators could cause serious injury or death.

According to a press release issued by CareFusion, the recall affects EnVe ventilators manufactured between December 2010 and May 2011. Problems with the recalled devices include:

• a potential delay in resuming ventilation after reconnection;
• a potential automatic reset;
• a potential for disconnection upon transport.

Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.

On September 12, CareFusion sent an Urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators. The notification included a list of serial numbers involved in the EnVe ventilator recall.

CareFusion is conducting a field corrective action to update the hardware and software on affected ventilators, the press release said.

News of the EnVe ventilator recall comes just one year after CareFusion recalled 17,000 electronic infusion pumps that at could suffer dangerous shut downs because of problems with wireless network connections. Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. As we reported at the time, that recall was also deemed Class 1 by the FDA.

CareFusion customers seeking more information about the EnVe ventilator recall can contact CarFusion Technical Support toll free at 800-554-8933.

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