CareFusion said it’s recalling all of its Avea ventilators over a possible pressure transducer failure that may cause the units to stop functioning.
A failure in the pressure transducer can lead to a false alarm in the device, which causes the units to stop ventilating, the company said. The failure resulted in a Class I status from the FDA, which denotes a risk of serious injury or death. No deaths or major injuries have been reported so far, CareFusion said.
A total of 15,905 units worldwide are affected by the recall, with 5,670 units in the U.S., according to the FDA. The devices under recall were manufactured between July 1, 2011, and March 15.
A letter informing customers to contact the the San Diego-based company is being sent to all customers who own an Avea ventilator, CareFusion said. The company is also coordinating on-site ventilator corrections with customers.