The Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) may kink during patient use. If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death. The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm386984.htm |