Class I Recall of CareFusion EnVe Ventilators - Leak In Patient Breathing Circuit or System
Published: Jul 24, 2012
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators manufactured from December, 2010 through January, 2012 and distributed from December, 2010 through May, 2012. A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. This product may cause serious adverse health consequences, including death.
The CareFusion EnVe ventilator is intended for continuous breathing support for the care of newborns through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care facilities. The firm sent an Urgent Product Recall letter to their customers.
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