The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious.
The recall was initiated after finding that glued connections may loosen before or during ventilation because of a manufacturing error. Partial or complete detachment of components may occur as a result and cause severe injury including lack of oxygen or death.
The company has received no reports of injuries or deaths related to this issue.
Distribution dates were January 1, 2019, to February 28, 2023.Read More >>