Due to a potential injury risk posed by a defective cuff balloon, a recall has been issued for 6,619 emergency cricothyrotomy kits that are used for opening the endotracheal airway.
The H&H Cricothyrotomy kits recall was announced by the FDA on October 4, due to a defective cuff balloon that may be subject to a reduction in package density or slippage of a protective silicon sleeve during shipping. No injuries or deaths have been reported in relation to the recall.
The Emergency Cricothyrotomy Kits are used for opening the endotracheal airway of a person which is located in the throat. The kits contain various tools for puncturing and splitting open the airway. Typically there is a tool used for puncturing and a scalpel used for cutting the opening.
The recalled Cricothyrotomy kits were manufactured by H&H Medical Corporation between August 16, 2012 and July 29, 2013 where they were sold within the Continental United States, primarily for U.S. military sale and use. Recalled kits may be identified by locating the lot number located on the top of the kit. For a full list of recalled lots numbers please visit http://www.fda.gov/Safety/Recalls/ucm370775.htm.
The FDA advises consumers with recalled Cricothyrotomy kits to immediately stop use, quarantine the product, and return it to their original place of purchase for immediate credit. H&H Medical Corp. is notifying its distributors and known customers by email and is encouraging any customers with questions to contact them at 804-642-3663 or by email at firstname.lastname@example.org.