According to the U.S. Food and Drug Administration (FDA), CareFusion has recalled nearly 16,000 Avea ventilators worldwide. The recall has been marked as Class I, which means users are at risk for serious injury or death.
The recalled Avea ventilator is used to comprehensively care for individuals with respiratory problems. Defective CareFusion ventilators have been used to treat infants, small children, and adults
According to the FDA, the pressure transducer on the machine can fail, causing the device to emit a false alarm. As a result of the false alarm, the units will stop ventilating.
This defect poses a serious threat to people who are dependent on the ventilator for medical reasons. CareFusion has announced that they are sending a letter out to all the consumers who own one of the recalled ventilators.