Recall Z-0006-2014 ยท BSK Cuff, Tracheal Tube, Inflatable
H & H Associates
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.
| Date | Oct 1, 2013 (initiated Aug 27, 2013) |
| Status | Terminated |
| Reason | Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. |
| Root 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 quarant |
| Quantity | 6,619 kits |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.