{ "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": "160042", "product_res_number": "Z-0345-2018", "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": "Adult Air-Life single-limb circuit (Model AH202) with 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": "0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134347 0001134348 0001135401 0001135402 0001137252 0001137253 0001139266 0001139267 0001145147 0001145148 0001145149 0001156843", "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" } } ] }