Class 1 Device Recall H&H Emergency Cricothyrotomy Kit

• Date Initiated by Firm: August 27, 2013
• Date Posted: October 01, 2013
• Recall Status: Terminated on January 13, 2015
• Recall Number: Z-0006-2014
• Recall Event ID: 66128
• Product Classification: Cuff, tracheal tube, inflatable - Product Code BSK
• Product: H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. ; ; The product is used to maintain fracture alignment.
• Code Information: Lots\EXP Dates: CKBD033, CKBE033 August 2015 CKBD034, CKBF034, CKBG034 August 2015 CKBP045 November 2015 CKBP047, CKBQ047 November 2015 CKBR060 February 2016 CKBT065 April 2016 CKBV070, CKBW070, CKBX070 May 2016 CKBX071 May 2016 CKBX076 June 2016 CKBX078 July 2016 CKBX079, CKBY079 July 2016 CKBY080, CKBZ080, CKCA080 July 2016.
• Recalling Firm/ Manufacturer: H & H Associates; 4173 G.W. Memorial Highway; Ordinary VA 23131
• For Additional Information Contact: Michelle Morgan; 804-642-3663
• Manufacturer Reason for Recall: Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
• FDA Determined Cause: Process change control
• Action: H&H Medical Corporation notified their customers by "Urgent Medical Device Recall" letter dated August 27, 2013 and advised that the cuff balloon wall may become weakened and rendered ineffective. The firm advised their customers to discontinue use and take steps to remove affected units from further use. The manufacturer will replace the current endotracheal airway and cuff within the kits identified with a new cuffed airway in its own sterile packaging. The recaller included two response forms for customers to return: The Acknowledgement of Recall Form is provided for those who can quarantine the Cricothyrotomy Kits indicated in the recall. The form confirms notification of this recall and discontinued use of affected devices and provides details regarding the accounting and quarantine of the product lots in question for return and correction. The Product Recall Replacement Part Request Form is only required when inventory quarantine is not feasible. This form acknowledges the receipt of this notification and the undersigned accepts the responsibility for affixing the replacement airways along with the instructions that H&H Medical Corporation will provide. The undersigned also assumes the responsibility to inform users regarding the subject of this recall, requires the use of the replacement airways over the airways provided in the affected kits and requires the disposal of the airways within the kits upon opening. For questions regarding the corrective request, please contact Ms. Michelle Morgan at 804-642-3663 or at mmorgan@gohandh.com during the hours of 8:00 a.m.-4:30 p.m. Eastern Standard Time, Monday through Friday.
• Quantity in Commerce: 6,619 kits
• Distribution: Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.