The FDA classified H&H Medical Corp.’s recall of its emergency cricothyrotomy kit as Class I.
The recall was issued because the kit’s endotracheal tube cuff balloon may not inflate properly.
H&H’s kit is designed for battlefield and 1st-responder trauma professionals. The inability of the cuff balloon to inflate can lead to aspiration and ineffective ventilation in the field. The federal watchdog agency noted that the recall is for products manufactured from August 07, 2012, to July 29, 2013, and distributed from August 16, 2012, to August 19, 2013.
H&H recommended that consumers who have a kit fitting the dates above stop using the affected product, remove affected products from inventory to quarantine, return the acknowledgement of recall form or product replacement part request form back to the company or return affected products to their original place of purchase for immediate credit or to request a replacement.