CareFusion Ventilator Recall Deemed Class I

<"">CareFusion EnVe Ventilators, model 19250-001, have been recalled in what the U.S. Food and Drug Administration (FDA) has deemed a Class I recall, its most severe and serious designation. Class I recalls involve situations in which there exists a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

The affected CareFusion EnVe Ventilators were manufactured between December 2010 and May 2011.

The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings. CareFusion 203, Inc., which is located at 17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341, issued the recall after identifying potential defects associated with the EnVe Ventilator model 19250-001 that can interrupt ventilation to the patient.

The issues include a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.

CareFusion is contacting facilities to coordinate hardware and software updates for affected ventilators. Customers with questions related to this recall may contact CareFusion Technical Support, toll-free, at 1.800.554.8933, Monday through Friday, 8:00 a.m. to 5:00 p.m., Pacific Time (PT).

On September 12, 2011, CareFusion sent an urgent product recall notification letter to its customers by certified mail, which provided required action for its customers and which also indicated that CareFusion would be contacting customers to coordinate a field corrective action to update the hardware and software on affected ventilators.

Last month, we wrote that news of the EnVe ventilator recall came 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.

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