H&H Emergency Cricothyrotomy Kits were recalled because the provided endotracheal airway may have a defective cuff balloon. A cricothyrotomy, a type of tracheotomy, is an emergency surgical procedure in which an incision in made through the neck into the windpipe in order to establish an airway. The cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway).
The recalled version of the H&H Emergency Cricothyrotomy Kit was produced between August 16, 2012 and July 29, 2013. The nationwide recall effects 6,619 units. H&H Medical Corporation distributed this product within the Continental United States, primarily for U.S. military sale and use.
See the Recall
See also Medical Law Perspectives, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue
See also Medical Law Perspectives, December 2012 Report: When Urgency Leads to Errors: Liability for Emergency Care