Walkup Melodia’s medical device attorneys handle cases across the country relating to government approved devices. Recently attorneys at the firm have been made aware of the FDA’s emergency recall of a potentially defective medical tool kit.
H&H Medical Corporation is recalling its H&H Emergency Cricothyrotomy Kit.
Some of these kits could have a defective endotracheal airway cuff balloon that many harm patients.
A cricothyrotomy is an emergency procedure which involves cutting a hole in a person’s cricothyroid membrane (Adam’s apple) to help them breathe when they are choking due to a closed or blocked airway – an emergent, life threatening condition.
Generally a cricothyrotomy is performed in an emergency situation, such as the scene of a car accident, whereas a tracheostomy is typically performed in an ICU.
The balloon cuffs in these kit may be defective to a variety of manufacturing and shipping defects including a reduction in package density, high doses of gamma sterilization, slipping silicon protection sleeves. The cuff is an important part of the kits as it helps stabilize the cricothyrotomy tube in the throat.
Officials from the U.S. Food and Drug Administration say that they have not received any reports of deaths or serious injuries associated with defective H&H Emergency Cricothyrotomy Kits.
The kit recall impacts units manufactured between August 16, 2012 and July 29, 2013 and distributed throughout the country.
Emergency crews who have purchased the cricothyrotomy kits have been advised to return their kits for a return credit or replacement.
The San Francisco Law Firm of Walkup, Melodia, Kelly & Schoenberger handled defective medical devices cases throughout the country. If you have been injured due to a defective H&H Emergency Cricothyrotomy Kit or any other kind of medical device, call us at 415-981-7210 or contact us online.