Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Emergency Cricothyrotomy Kit, manufactured by H&H Medical Corporation. The affected products are identified as follows:-

• Lot number: CKBD033, CKBE033, CKBD034, CKBF034, CKBG034, CKBP045, CKBP047, CKBQ047, CKBR060, CKBT065, CKBV070, CKBW070, CKBX070, CKBX071, CKBX076, CKBX078, CKBX079, CKBY079, CKBY080, CKBZ080, CKCA080
• The products were manufactured from 16 August 2012 and 29 July 2013

The manufacturer initiated a nationwide recall of 6,619 units of the H&H Emergency Cricothyrotomy Kit on 27 August 2013. The product has been found to show 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, the FDA and the manufacturer have not received any injuries or deaths.

The manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products.

For details, please visit the following FDA websites:

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370781.htm
• http://www.fda.gov/Safety/Recalls/ucm370775.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 7 October 2013