Teleflex has issued a global recall of several lots of its Hudson RCI Sheridan Endotracheal Tubes after receiving four reports of death and additional reports of serious injury, according to a notice on the FDA's website.
Complaints sent to the device manufacturer said there is an increased incidence of the Sheridan connector becoming disconnected from the endotracheal tube, which may result in the patient not obtaining sufficient oxygen.
The FDA has classified the recall as a Class 1, defined as a situation where the product will cause serious adverse health consequences or death.
Teleflex said customers who have the affected product should immediately discontinue use and return it.
Access the list of affected products here.