FDA: Class I recall of Baxter’s Volara system with in-line ventilator adaptor

Editor's Note

The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious.

The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary atelectasis.

The recall was initiated because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators.

There has been one complaint, one injury, and two deaths associated with this device.

Distribution dates were May 28, 2020, to April 19, 2022.