Teleflex Tracheal Tube Gets Class I Recall Status

Teleflex Medical Inc.'s voluntary recall of a faulty tracheal tube has received a Class I designation from the FDA, which means there is a "reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."Research Park Triangle, NC-based Teleflex Medical, part of Limerick, PA-based Teleflex Inc., announced the Class I designation on Wednesday. It involves Teleflex's ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet). The recall comes after complaints the company that the tracheal tube can kink during patient use, creating a life-threatening situation. Teleflex started the recall through a letter to its U.S. customers on January 6, 2014.

The Teleflex ISIS HVT was meant to meet the needs of patients requiring both short- and long-term ventilation, without the need to change tubes. It includes a separate line for subglottic secretion suctioning, which can help prevent ventilator-associated pneumonia among patients who are using a ventilator long-term.Now customers are being told to immediately discontinue use of the recalled devices and return all unused ISIS products to Teleflex Medical. A full list of affected product codes is included with the Teleflex news release.