{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160040", "product_res_number": "Z-0343-2018", "event_date_initiated": "2014-11-29", "event_date_posted": "2018-01-24", "recall_status": "Terminated", "event_date_terminated": "2021-02-05", "res_event_number": "78636", "product_code": "BTT", "k_numbers": [ "K160764" ], "product_description": "Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290.\n\nThe AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.", "code_info": "CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23", "firm_fei_number": "2050001", "recalling_firm": "Vyaire Medical", "address_1": "75 N Fairway Dr", "city": "Vernon Hills", "state": "IL", "postal_code": "60061-1845", "reason_for_recall": "Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.", "root_cause_description": "Process control", "action": "The firm, Vyaire Medical, sent an \"URGENT RECALL NOTIFICATION\" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following:\n\"ALL CUSTOMERS:\n~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk.\n~ Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol.\n~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION.\n\nCUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE:\n~ Complete the Customer Response Form (Appendix 2) and return to GMB-GLBALFieldActions@CareFusion.com\n~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST.\n\n*Please have your original PO number available when calling to expedite the credit process.\n\nCUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR:\n~ Please work with your distributor to receive credit of your in-stock product affected by this recall.\n\nFor any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or lindy.schenning@vyaire.com.", "product_quantity": "16,670 units in total", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K162242", "K881970", "K872138", "K253479", "K080149", "K791683", "K923754", "K013856", "K242717", "K792620", "K920306", "K211096", "K003561", "K163283", "K141353", "K110019", "K760866", "K915890", "K073706", "K833974", "K903138", "K233707", "K133766", "K801252", "K831163", 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"3004213967", "3043226252", "3002808440", "3000126629", "3013517171", "2523148" ], "device_name": "Humidifier, Respiratory Gas, (Direct Patient Interface)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5450", "device_class": "2" } } ] }