A medical company has issued a worldwide recall for several types of endotracheal tubes after it received four reports of patient deaths and more instances of severe injury in patients using its products. Teleflex Incorporated said the recall affects certain lots of Hudson RCI@ Sheridan@ Endotracheal Tubes, which are designed for oral or nasal intubation to help patients with airway management.
“This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT),” the company said in a recall notice posted on the FDA website. “There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a factor.”
According to the notice the FDA classified it as a “Class I recall,” which is designated in situations in which “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The company said patients should immediately discontinue use of impacted products and return it to Teleflex or a distributor. Those with additional questions are instructed to contact the company at (866) 396-2111.