The recall of a batch of CareFusion's Avea ventilators earlier this fall has been deemed a Class I recall, the Food and Drug Administration said Thursday. Class I recalls involve the risk of injury or death.
CareFusion voluntarily began the recall in September, and it only affects those Avea ventilators made between March 1, 2009 and June 30, 2011, the FDA said.
In letters sent to customers, the company explained that defective versions of the device would occasionally trigger a false alarm, in which it would stop ventilating the patient. The patient could then be hurt if doctors didn't provide alternative ventilation, the company said.
CareFusion is visiting sites with the device and making field corrections, according to notices sent to customers.