The FDA alerted the public on October 4 of H&H Medical Corporation’s recall of its Emergency Cricothyrotomy Kits. H&H Medical distributed cricothyrotomy kits—used for emergency airway obstruction relief—nationwide, primarily for U.S. military use. The recalled trauma kits—used in emergency situations where no other ventilation method is appropriate or effective—have defective cuff balloons due to reduction in package density, higher than average dose of gamma sterilization, and slippage of the protective silicon sleeve during shipping. The defective cuff balloon (pictured above) is located at the end of the kit’s 6.0mm endotracheal tube and is designed to maintain an open airway; therefore, a defective endotracheal cuff balloon could inhibit life-saving measures and could damage the patient’s windpipe.
H&H Medical manufactures first aid trauma kits for use by medical personnel in emergency situations. Trauma personnel use emergency cricothyrotomy kits to open a patient’s airway, similar to a tracheotomy. Because of the risks associated with a cricothyrotomy, and the difficulty of performing emergency airway obstruction relief in a field situation, cricothyrotomy kits should only be used when necessary for the life of the patient. The balloon cuff, the defective component of H&H Medical’s cricothyrotomy kits, is designed to prevent damage to the windpipe during emergency procedures.
H&H Medical recalled more than 6,600 cricothyrotomy kits. All lots produced from August 16, 2012 – July 29, 2013, have been recalled, including lot numbers:
- CKBD033, CKBE033, CKBD034, CKBF034, CKBG034 (Expiration 8/2015)
- CKBP045, CKBP047, CKBQ047 (Expiration 11/2015)
- CKBR060 (Expiration 2/2016)
- CKBT065 (Expiration 4/2016)
- CKBV070, CKBW070, CKBX070, CKBX071 (Expiration 5/2016)
- CKBX076 (Expiration 6/2016)
- CKBX078, CKBX079, CKBY079, CKBY080, CKBZ080, CKCA080 (Expiration 7/2016)
The H&H Emergency Cricothyrotomy Kit is standard issue in multiple U.S. military trauma kits. All affected kits should be immediately quarantined from inventory and returned to original place of purchase.
Although H&H Medical distributed cricothyrotomy kits primarily for U.S. military use, the defective devices were distributed nationwide and used in a variety of critical care and emergency settings. If you or a loved one may have been affected by a faulty cricothyrotomy kit or other medical device, please call us today at 1-800-644-1734.
