CareFusion Issues Update Regarding Recall Of AVEA Ventilators - Quick Facts

(RTTNews) - CareFusion (CFN) Monday said, the previously announced voluntary recall of AVEA ventilators by the FDA is classified as a Class I recall. Class I recall is carried out if probability of serious adverse health consequences or death associated with use of the defective units.

AVEA ventilators were earlier recalled, due to possible under reporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor. As such, the patient may receive a higher than expected tidal volume.

Moreover, hospitals in locations higher than 5,000 feet above sea level that are using the AVEA ventilator in the neonatal patient care setting have the greatest risk of this error. This is because, the level of underreporting between displayed flow and actual flow increases proportionately with altitude.

So far, the company has received five complaints from a facility that was operating in the neonatal patient care settings and was located higher than 5,000 feet above sea level.