The U.S. Food and Drug Administration recently notified healthcare professionals of a Class I recall of CareFusion AVEA Ventilators. Ventilators provide continuous breathing support for the care of patients who require mechanical ventilation. The AVEA ventilator has the ability to automatically shut off under certain circumstances. The FDA issued the Class I recall because a false alarm within the ventilator has been known to stop ventilation and thus cease to provide respiratory support.
Class I recalls are reserved for defective products that predictably pose life-threatening injuries. Thankfully, the FDA initiated the recall of the AVEA ventilators before this fatal glitch resulted in tragedy.
