H and H Medical Corporation (formerly H and H Associates) Emergency Cricothyrotomy Kit – Cuff Balloon May Not Function as Intended
Recall Class: Class I
Date Recall Initiated: August 27, 2013
Product: H&H Emergency Cricothyrotomy Kit
Lot Numbers/Expiration Date:
To locate lot numbers and expiration dates of affected products, refer to FDA's Class I Recall information under "Additional Links" below.
The affected products were manufactured from August 07, 2012 to July 29, 2013 and distributed from August 16, 2012 to August 19, 2013.
Use: The Emergency Cricothyrotomy Kit is designed for battlefield and first responder trauma professionals and used in emergency situations where a person’s breathing is stopped due to blockage in the face or throat. The Emergency Cricothyrotomy Kit contains the tools needed to perform a cricothyrotomy, a surgical procedure used to gain quick access to an otherwise compromised and inaccessible airway.
H & H Medical Corporation (formerly H&H Associates)
4173 G.W. Memorial Highway
Ordinary, Virginia 23131
Reason for Recall:
The cuff balloon on the endotracheal (windpipe) tube may become weakened and not inflate when in use, causing the product to be ineffective.
The defective cuff balloon may be caused by a combination of circumstances: a reduction in package density, a higher than average dose of gamma sterilization, and the rare slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal tube.
This product may result in serious adverse health consequences such as aspiration and ineffective ventilation, leading to respiratory arrest and/or death.
Public Contact: Customers with questions are directed to contact H&H Associates at 804-642-3663 (Mon. – Fri., 8 am to 4:30 pm Eastern Time) or by e-mail at firstname.lastname@example.org.
FDA District: Baltimore District Office
On August 27, 2013, H & H Medical Corporation notified its customers of the problem by mail and asked them to do the following:
- Stop using the affected products
- Remove affected products from inventory to quarantine
- Return the Acknowledge of Recall Form or Product Replacement Part Request Form back to the company
- Return affected product to their original place of purchase for immediate credit or to request a replacement
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.