Draeger Breathing Hose Recall Deemed Class I by FDA
The FDA has deemed Draeger’s recall of several of its breathing hose components as Class I, the most serious type of recall, because of the potential that glued connections in the breathing circuits could detach, leading to serious injuries or death.
Draeger first recalled various models of its Seattle-Positive Airway Pressure (PAP) system on April 17. The products support breathing for infants in respiratory distress as well as breathing circuits and/or anesthesia kits used with ventilators in an intensive care unit or during surgery for infants, children and adults.
The company explained that the glued connections of the breathing circuits may loosen before or during the ventilation process, resulting in partial or complete detachment of components such as the water trap, y-piece or hose connector. The company has not received any reports of injuries or deaths related to this potential risk.
The company says it has implemented changes to the gluing process and began distributing updated Seattle PAP products March 20. Testing is still ongoing for the remaining circuits, and all impacted customers have been offered an alternative product as a temporary replacement.
A list of affected products can be found here.