FDA Provides Update on Baxter’s Recall of Volara System for Respiratory Treatment

The FDA has issued on update on Baxter’s April 26 recall of its Volara System for respiratory patients, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is that the device’s in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The 268 affected products, which bear product model numbers PVLIHCBA, M08594 and M08594A, were distributed from May 28, 2020 to April 19 of this year.

The Volara system is intended to help people clear mucus out of their airways, expand the lungs, and treat or prevent a partially collapsed lung. The system’s in-line ventilator adaptor component is meant to make it possible for it to be used together with an in-line ventilator in home-care settings.

Two deaths have been associated with the use of the device, the agency said.