Device 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.
Z-0006-2014
Product summary
- Firm
- H & H Associates
- Event
- Event 66128
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6,619 kits
- Official record key
device-enforcement:Z-0006-2014
Official wording
Reason: Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
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.
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.