Teleflex Medical of Research Triangle Park, NC, sent their customers an Urgent Medical Device Recall Notification about its ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet). A tracheal tube is a device inserted into a patient’s windpipe through the nose or mouth and used to maintain an open airway.
The recalled tracheal tube 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe