Teleflex Medical has announced a voluntary recall of one of its tracheal tubes, which, it says, can kink during use and cause serious injury by depriving patients of adequate ventilation.
The FDA has classified the recall as Class I, a designation it uses when it believes there is "a reasonable possibility [of] serious health consequences or death."
Teleflex initiated the recall of the "ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet)" in a January 6 letter to U.S. customers. The company is asking all customers to immediately stop using the devices and return all unused ISIS.
Customers with questions can reach the company at (866) 804-9881.