October 07, 2013
Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway
AUDIENCE: Health Professional, Risk Manager, Critical Care
ISSUE: On August 27, 2013, H&H Medical Corporation initiated a nationwide recall of 6,619 units of the H&H Emergency Cricothyrotomy Kit. The product has been found to have the potential for a defective cuff balloon on the provided endotracheal airway. The cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway). To date, no injuries or deaths have been reported to H&H or to the FDA.
BACKGROUND: The product lot number can be identified by a lot number and manufacture label applied at the top opening of the kit. The recalled version of the H&H Emergency Cricothyrotomy Kit was produced between August 16, 2012 and July 29, 2013. See firm press release for complete list of lot numbers.
RECOMMENDATION: Consumers who have product should stop using the product and return them to their original place of purchase for immediate credit. Distributors are instructed to return all recalled items meeting the lot numbers listed below for return credit or for immediate replacement. Users should quarantine this product from inventory and return it to the original source of sale for credit or to request immediate replacement.Consumers with questions may contact H&H Medical Corporation via telephone at 800-326-5708 between the hours of 8 a.m. and 4:30 p.m. (Eastern Time Zone) or contact the company via e-mail at firstname.lastname@example.org.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370781.htm