{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121529", "product_res_number": "Z-0006-2014", "event_date_initiated": "2013-08-27", "event_date_posted": "2013-10-01", "recall_status": "Terminated", "event_date_terminated": "2015-01-13", "res_event_number": "66128", "product_code": "BSK", "product_description": "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***. \r\n\r\nThe product is used to maintain fracture alignment.", "code_info": "Lots\\EXP Dates:  CKBD033, CKBE033\tAugust 2015 CKBD034, CKBF034, CKBG034\tAugust 2015 CKBP045\tNovember 2015 CKBP047, CKBQ047\tNovember 2015 CKBR060\tFebruary 2016 CKBT065\tApril 2016 CKBV070, CKBW070, CKBX070\tMay 2016 CKBX071\tMay 2016 CKBX076\tJune 2016 CKBX078\tJuly 2016 CKBX079, CKBY079\tJuly 2016 CKBY080, CKBZ080, CKCA080\tJuly 2016.", "firm_fei_number": "3003339833", "recalling_firm": "H & H Associates", "address_1": "4173 G.W. Memorial Highway", "city": "Ordinary", "state": "VA", "postal_code": "23131", "additional_info_contact": "Michelle Morgan\n804-642-3663", "reason_for_recall": "Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.", "root_cause_description": "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. \r\nThe 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: \r\nThe 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. \r\nThe 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.", "product_quantity": "6,619 kits", "distribution_pattern": "Nationwide distribution.", "openfda": { "k_number": [ "K142103", "K912723", "K191858", "K102704", "K881514", "K831577", "K192611", "K173914", "K180991", "K112915", "K202874", "K923800", "K092733", "K122721", "K221477", "K150893", "K261499", "K243562", "K220854", "K884638", "K150157", "K902114", "K113644", "K792265", "K833327", "K152778", "K873614", "K102674", "K973755", "K881178", "K901255", "K081805", "K912352", "K951046", "K110631", "K182548", "K900755", "K885216", "K242642", "K152865" ], "registration_number": [ "3003935342", "2182318", "3007740622", "3006024395", "3004992992", "3014766741", "3016438694", "3018094310", "8010485", "1417592", "3007048256", "2951529", "3007014520", "3030412764", "2936999", "3009973505", "3004365956", "2518436", "9616567", "3016548968", "1047843", "3042254935", "3029906224", "2025816", "3018226067", "3009307931", "2031966", "8010939", "3010326740", "3009959868", "1314417", "3004593495", "3007713076", "3005803389", "3007682555", "3011481350", "1056553", "3010806663", "3011137372", "3043543260", "3014254831", "2022648", "1221763", "3006673317", "3009050824", "3012072872" ], "fei_number": [ "3003935342", "3003361161", "2182318", "3002980729", "3005747797", "3007740622", "3006024395", "3004992992", "3014766741", "3016438694", "3018094310", "1417592", "1000307109", "3007048256", "3007014520", "3030412764", "2936999", "3009973505", "3004365956", "2518436", "3016548968", "1047843", "3042254935", "3029906224", "2025816", "3002963732", "3018226067", "1000132370", "3005596530", "3009307931", "3010326740", "3009959868", "1314417", "3004593495", "3007713076", "3005803389", "3007682555", "3011481350", "3010806663", "3043543260", "3002808440", "3014254831", "2022648", "1221763", "3009050824", "3012072872" ], "device_name": "Cuff, Tracheal Tube, Inflatable", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5750", "device_class": "2" } } ] }