FDA announces Class 1 recall for ventilator adapter assemblies

Editor's Note

The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death.

The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit components that are used to connect the Volara System to the ventilator. According to the September 4 FDA announcement, the recall was motivated by reports of the handset plug disconnecting from the nebulizer point on the blue ventilator adaptor. Disconnecting the plug can disrupt ventilation, resulting in desaturation and subsequent brain injury, heart attack, respiratory failure and death.

There have been no reported injuries or deaths.