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.

Recall number

Z-0006-2014

Recalling firm

H & H Associates

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.

Status

Terminated

Initiated

2013-08-27

Posted

2013-10-01

Terminated

2015-01-13

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 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

6,619 kits

Distribution

Nationwide distribution.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

BSK

Firm FEI

3003339833

Firm city

Ordinary

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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