{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198232", "product_res_number": "Z-1272-2023", "event_date_initiated": "2022-12-16", "event_date_posted": "2023-03-17", "recall_status": "Open, Classified", "res_event_number": "91579", "product_code": "BTT", "k_numbers": [ "K111640" ], "product_description": "Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW", "code_info": "UDI-DI: 00841737104971, Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567;\n\nUDI-DI: 00841737104978, Lot Number: LFVLE8568\n\nAdditional Lot Numbers: LFTL41015\nLFVLC8399\nLFVLE8495\nLFVMA8502\nLFVMA8503\nLFVMA8504\nLFVMA8567\nLFTL41261\nLNTL41544\nLFVLE8588\nLFVMA8507\nLFVLE8568\nLFVLE8494\nLFTL41263\nLFTL41262", "firm_fei_number": "3012971441", "recalling_firm": "Vapotherm", "address_1": "100 Domain Dr", "city": "Exeter", "state": "NH", "postal_code": "03833-4801", "reason_for_recall": "There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.", "root_cause_description": "Nonconforming Material/Component", "action": "A Technical Bulletin dated 10/27/22 was distributed to customers. \n\nVapotherm has learned of certain Low Flow Disposable Patient Circuit (DPC) lots exhibiting excessive condensation. Please find the affected DPC lots in the attached appendix. You have been identified as a customer that received some or all of these lots. This condensation can be mitigated by ensuring that the delivery tube is fully primed and warm before placing the therapy on the patient, per existing instructions for use.\n\nAlways check that the delivery tube is warm across the entire length before placing the therapy on the patient. If you experience delivery tubes that are not circulating water or are cold, do not use. Please contact Vapotherm Technical Support to report the issue. For every incident reported, we will replace and ship out a new DPC as soon as possible at no cost to you.\n\nThank you for your continued support of Vapotherm and providing your patients with optimal care.\nIf you have any questions, please contact Vapotherm Technical Support:\nFor US customers, ts@vtherm.com or 855 557 8276\nFor UK customers, ukinfo@vtherm.com or +44 0345 305 8098\nFor all other customers, please reach out to your Vapotherm distributor.\n\nAn Urgent Field Safety Notice dated 12/16/22 was sent to customers in the UK. \n\nVapotherm requests that you return any unused products of the lots detailed below. Unused products from the affected lots should be returned as described in the Required Actions section within the FSN. This product removal is limited to the product codes / lot numbers listed below. No other product codes or lot numbers are affected.\n\nRequired Actions to be taken by the VAPOTHERM:\n1.For any unused product of the affected lots, replace affected DPC lots.\n2.Email Customer Acknowledgment Form to impacted customers.\n3.Ensure completion of Customer Acknowledgement Form.\n\nRequired Actions to be taken by the END USER/ HEALTHCARE ORGANIZATION:\n1.Inspect your inventory, locate any unused units of the af", "product_quantity": "5869 total", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of UK.", "openfda": { "k_number": [ "K923946", "K903138", "K161719", "K831163", "K964653", "K234058", "K872138", "K211096", "K880702", "K254078", "K843903", "K971260", "K993282", "K760566", "K010402", "K902970", "K080797", "K983783", "K884150", "K122705", "K143646", "K915460", "K222351", "K791683", "K003561", "K042184", "K131912", "K241778", "K820878", "K000401", "K760923", "K863955", "K141353", "K833974", "K802145", "K070714", "K060790", "K810939", "K063758", "K780562", "K832928", "K923754", "K201723", "K841158", "K901762", "K842523", "K242717", "K854363", "K250312", "K885314", "K991484", "K251448", "K864173", "K834151", "K062091", "K131957", "K842794", "K810559", "K231956", "K801619", "K853146", "K071958", "K780385", "K851879", "K072845", "K842340", "K070107", "K012633", "K882582", "K103316", "K013486", "K001213", "K223863", "K191010", "K770249", "K893122", "K881184", "K760584", "K962223", "K102618", "K160764", "K792620", "K073706", "K926161", "K041963", "K953392", "K240163", "K131388", "K121975", "K893034", "K990614", "K800056", "K823143", "K760372", "K781760", "K090915", "K180474", "K131895", "K230559", "K132857", "K850647", "K983862", "K760037", "K140556", "K223551", "K900854", "K770415", "K870173", "K822816", "K203357", "K811073", "K892817", "K031176", "K950582", "K062664", "K251419", "K780845", "K072982", "K002454", "K100554", "K020700", "K800753", "K113542", "K936000", "K993773", "K970478", "K945782", "K881970", "K781537", "K162242", "K781468", "K760938", "K220703", "K080149", "K831556", "K863154", "K915890", "K191818", "K141940", "K050990", "K900602", "K760866", "K132017", "K802144", "K110019", "K013856", "K842795", "K163283", "K993355", "K851940", "K801252", "K863377", "K033710", "K133766", "K870055", "K830913", "K913368", "K122885", "K092846", "K873472", "K042245", "K780088", "K093617", "K050314", "K052615", "K913367", "K040507", "K223684", "K781600", "K222292", "K092256", "K873634", "K872139", "K162553", "K061736", "K231380", "K233821", "K880979", "K003973", "K111640", "K761293", "K760587", "K780381", "K874659", "K212031", "K894000", "K993268", "K983112", "K790731", "K152029", "K251611", "K932570", "K253479", "K843932", "K812957", "K031383", "K233707", "K020332", "K193411", "K802852", "K810219", "K841851", "K934140", "K010578", "K871618", "K222197", "K911770", "K070056", "K262268", "K030090", "K900569", "K896315", "K963025", "K003626", "K920306", "K031179", "K962079", "K161314", "K841295", "K862923", "K020900", "K914686" ], "registration_number": [ "9610849", "3010063021", "3043709870", "3011120183", "3010817335", "3012494290", "2132517", "3048101987", "3029706818", "9710641", "3003799815", "3006606984", "2523148", "2024500", "3012421607", "3011790297", "3010476117", "3013517171", "9680661", "3006636961", "3030446844", "3009129579", "9616874", "2085602", "3042507287", "3030733800", "3018900343", "3008567544", "3006785496", "3013820501", "3002797442", "9611451", "3012971441", "9710644", "8010042", "3006061749", "3006467300", "3004050971", "3014766741", "3015928685", "3004748541", "3021947238", "3012316249", "3043226252", "3008264065", "8043316", "8010939", "3018783526", "3016052406", "3001421318", "3014499739", "9615827", "3044994756", "8021995", "1423662", "3015537026", "1924066", "3013095415", "3004111573", "3006783791", "3008806809", "1526863", "2518422", "1420032", "8030673", "3011987967", "3003135857", "3005998497", "2244684", "1417411", "3042226221", "3001313714", "3030308442", "3016723884", "3023272766", "3029906224", "3005440755", "1417592", "3007573469", "3013557562", "3008770104", "3007238566", "3017235290", "2025816", "3007502289", "3003898360", "1417519", "9616567", "1625392", "3002807267", "3004365956", "9617566", "3023209222", "3030149975", "3010272829", "1314417", "3011971979", "1225492", "3011137372", "3030089838", "3000126629", "8043439", "3018094310", "3021039857", "3016450067", "3004604967", "2028807", "3005587132" ], "fei_number": [ "3002808696", "3003565456", "3010063021", "3043709870", "3003949221", "3011120183", "1000221012", "3010817335", "3012494290", "3048101987", "3029706818", "3003799815", "3006606984", "2523148", "2024500", "3002807391", "3012421607", "1000115734", "3011790297", "3010476117", "3013517171", "3006636961", "3030446844", "3009129579", "3000210616", "3042507287", "3030733800", "3018900343", "3008567544", "3006785496", "1000374126", "3013820501", "3002797442", "3012971441", "3006061749", "3006467300", "3004050971", "3014766741", "3015928685", "3005747797", "3004748541", "3021947238", "3001237338", "3002963732", "3012316249", "3043226252", "3008264065", "1000058335", "3018783526", "3016052406", "3001421318", "3014499739", "3044994756", "3006363476", "3015537026", "3003080079", "3004213967", "3000215273", "1924066", "3013095415", "3004111573", "3006783791", "3008806809", "1526863", "2518422", "3002808128", "1420032", "3011987967", "3003135857", "3005998497", "2244684", "1417411", "3042226221", "3030308442", "3016723884", "3023272766", "3029906224", "3005440755", "1417592", "3002808440", "3013557562", "3008770104", "3007238566", "3017235290", "2025816", "3007502289", "3002807293", "3003898360", "3003244771", "1417519", "3002807267", "3006403682", "3004365956", "3023209222", "3030149975", "3004411059", "3010272829", "3002806988", "1314417", "3011971979", "3030089838", "3000126629", "3018094310", "3021039857", "3016450067", "3004604967", "3003319165", "3005587132" ], "device_name": "Humidifier, Respiratory Gas, (Direct Patient Interface)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5450", "device_class": "2" } } ] }