Teleflex Inc. announced a worldwide recall of certain Hudson RCI@ Sheridan@ Endotracheal Tubes, which are used during oral or nasal intubation for airway management.
The recalled endotracheal tubes were distributed from October 2016 to May 2019. Specific lot codes can be found on the FDA recall notice.
The recall was issued after complaints indicating that there is an increased risk of specific lots of the 15-mm Sheridan connector becoming disconnected from the endotracheal tube.
The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention.”
There have been 4 reports of death, as well as reports of serious injuries where endotracheal tube disconnection may be a factor.
The FDA has classified the recall of Hudson RCI® Sheridan® Endotracheal Tubes as a Class I recall, which is the most serious level of recall. It is reserved for situations where use of the recalled device has a reasonable risk of causing severe injury or death to patients.