{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 69 } }, "results": [ { "cfres_id": "216013", "product_res_number": "Z-0158-2026", "event_date_initiated": "2025-09-18", "event_date_posted": "2025-10-15", "recall_status": "Open, Classified", "res_event_number": "97591", "product_code": "BTT", "k_numbers": [ "K131895" ], "product_description": "Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723", "code_info": "REF/UDI-DI:\nPT101US/9420012422347;\nPT100US/9420012422248.\n\nDisinfection Kit User Manual all revisions before UI-185043723 rev P", "firm_fei_number": "3002806988", "recalling_firm": "Fisher & Paykel Healthcare, Ltd.", "address_1": "15 Maurice Paykel Place", "city": "Auckland", "state": "East Tamaki", "country": "New Zealand", "additional_info_contact": "649-574-0100", "reason_for_recall": "When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.", "root_cause_description": "Nonconforming Material/Component", "action": "On 9/18/2025, correction notices were communicated via email and phone call. Customers were asked to do the following:\n\n1) Prior to use on a new patient, follow the instructions of the updated Disinfection Kit User Manual.\n2) If you have distributed affected devices, notify your customers and include a copy of this notice.\n3) Please report all device-related incidents to the firm, distributor or local representative.\n3) Complete and return the response form via email to FieldActionUSCA@fphcare.com\n\nThe Disinfection Kit User Manual updated to include:\n\n7a: Perform Power-Out Alarm test\nEnsure steps 1-6 have been carried out, so that the alarm circuit is charged . Unplug the unit from the mains/utility power socket .\nCheck that the audible alarm sounds for at least 120 seconds . The unit is now ready for storage .\n\nUser Manuals can be downloaded from the following links:\nAirvo 2: https://resources.fphcare.com/content/airvo-manual-uk-us-and-az-ui-185045495-h-15thmarch22.pdf\nmyAirvo 2: https://resources.fphcare.com/content/myairvo2-user-manual-ui-185045490.pdf\nDisinfection Kit: https://resources.fphcare.com/content/airvo-2-disinfection-manual-user-instructions-ui-185043723.pdf\n\nPlease note, as per the \"Technical Information\" section of the Product Technical Manual and the User Manual, the expected service life is 5 years.\n\nIf you have any questions, please contact the firm's Customer Care via email at FieldActionUSCA@fphcare.com or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.", "product_quantity": "51,144", "distribution_pattern": "US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.", "openfda": { "k_number": [ "K003973", "K072845", "K061736", "K250312", "K900854", "K993355", "K862923", "K242717", "K143646", "K212031", "K880702", "K251419", "K893122", "K020700", "K253479", "K792620", "K822816", "K830913", "K863955", "K802144", "K042245", "K040507", "K071958", "K062091", "K063758", "K254078", "K073706", "K191818", "K090915", "K133766", "K251448", "K220703", "K831556", "K230559", "K031179", "K873472", "K780088", "K962223", "K900569", "K841158", "K911770", "K002454", "K131895", "K241778", "K203357", "K132017", "K222197", "K800753", "K020332", "K885314", "K031383", "K873634", "K092846", "K060790", "K851940", "K223863", "K233821", "K163283", "K843932", "K993268", "K923946", "K780845", "K193411", "K843903", "K842523", "K010578", "K810559", "K223684", "K162242", "K233707", "K030090", "K141940", "K945782", "K810219", "K863377", "K894000", "K131388", "K770415", "K201723", "K882582", "K841851", "K923754", "K842794", 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