{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190581", "product_res_number": "Z-0468-2022", "event_date_initiated": "2021-12-09", "event_date_created": "2022-01-10", "recall_status": "Open, Classified", "res_event_number": "89125", "product_code": "BSZ", "k_numbers": [ "K191027" ], "product_description": "Vaporizer Sevoflurane Maquet Filling, Part No. 6886601\n\nComponent of the following systems: \nProduct Code(s) UPN/UDI:\nFlow-c Anesthesia System 6887700 07325710009765\nFlow-e Anesthesia System 6887900 07325710010457\nFlow-i Anesthesia System C20 6888520 07325710010617\nFlow-i Anesthesia System C30 6888530 07325710010624\nFlow-i Anesthesia System C40 6888540 07325710010631\nFlow-i C20 Anesthesia System 6677200 07325710001349\nFlow-i C30 Anesthesia System 6677300 07325710001349\nFlow-i C40 Anesthesia System 6677400 07325710001318", "code_info": "UDI: 07325710008430\n\nSerial Nos. \n15580\n15890\n15924\n16284\n16637\n16837\n16970\n15582\n15891\n15925\n16285\n16638\n16840\n16971\n15721\n15894\n16268\n16345\n16639\n16842\n15722\n15914\n16269\n16352\n16640\n16843\n15725\n15917\n16270\n16354\n16690\n16844\n15726\n15919\n16271\n16632\n16828\n16961\n15728\n15920\n16272\n16633\n16832\n16964\n15729\n15921\n16273\n16634\n16833\n16965\n15731\n15922\n16276\n16635\n16834\n16966\n15732\n15923\n16283\n16636\n16836\n16968", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "additional_info_contact": "Stephanie Moretti\n973-709-7170", "reason_for_recall": "A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.", "root_cause_description": "Under Investigation by firm", "action": "On December 9, 2021, the firm began distribution of Urgent Medical Device Recall letters to affected customers. Customers were informed of the product issue and potential risks to health, which may include irritation of respiratory tract and in worst case may lead to lung edema and/or severe hypocalcemia which may be delayed for 24-48 hours after exposure.\n\nActions to be taken by the Customer:\n\n\" Please examine your inventory immediately to determine if you have any of the\nVaporizer Sevoflurane, Maquet Filling with the product codes/serial numbers listed in\nthis notice.\n\n\" Should you have any affected product, please remove from areas of use.\n\n\" If you have affected product you are entitled to a credit or replacement; however,\nreplacements for use with Sevoflurane from Baxter and Piramal will not be\navailable for some time.\n\n\" If you use agents from AbbVie ONLY, you can be provided a\nreplacement Vaporizer, Model 6886601, by certifying use of AbbVie\nagents only on the Medical Device Recall Response Form on page 5.\n\n\" Please contact Getinge Customer Service at 888-943-8872 (press option 2) to\nrequest a return authorization (RMA) and shipping instructions to return any affected\nproduct. Pack the product to be returned with the appropriate return documents and,\nusing the shipping instructions provided, arrange for pickup with the designated\ndelivery service provider.\n\n\" Please enter the serial number and your RMA number provided by Customer Service\nin the spaces provided on the Medical Device Recall Response Form on Page 5 of\nthis letter.\n\n\" If at any time, should the user notice that the agent in the vaporizer looks cloudy and\nyellowish and/or detect a sweet-smelling pungent odor, the user should immediately\nstop use of the affected vaporizer.\n\n\" To prevent exposure, the user should be able to successfully perform a System\nCheck-Out (SCO) procedure which may detect the failure prior to usage. If the gas\nanalyzer test fails, a dialog box will appear to promptly inform t", "product_quantity": "50 US; 898 OUS", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of VA and MO. The countries of Austria, Bahrain, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Estonia, Iraq, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Morocco, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K884879", "K930351", "K113633", "K252746", "K802591", "K073707", "K052335", "K151570", "K884802", "K972848", "K830159", "K973896", "K890410", "K861170", "K875350", "K041430", "K945463", "K852175", "K801103", "K872178", "K853435", "K061102", "K083098", "K882489", "K862085", "K001727", "K201957", "K930492", "K971425", "K160665", "K963994", "K903991", "K123211", "K172045", "K844421", "K072420", "K081844", "K921742", "K251352", "K142552", "K133886", "K771057", "K230931", "K840356", "K833335", "K801102", "K900937", "K171292", "K864644", "K102471", "K963481", "K822218", "K841274", "K032803", "K913791", "K894309", "K030624", "K850648", "K081447", "K041622", "K844849", "K103035", "K770554", "K973971", "K062155", "K973949", "K042154", "K042607", "K131945", "K781492", "K000859", "K033026", "K112114", "K982137", "K844012", "K893780", "K110213", "K132903", "K965041", "K965160", "K031400", "K170872", "K945722", "K003251", "K901713", "K010613", "K191027", "K902962", "K003579", "K042086", "K143530", "K830161", "K844008", "K935546", "K973985", "K001488", "K900328", "K841370", "K920944", "K884991", "K140264", "K253330", "K090892", "K760228", "K033498", "K083413", "K970163", "K122445", "K132530", "K933285", "K900329", "K833147", "K992421", "K863207", "K003663", "K974193", "K022031", "K853139", "K001315", "K171311", "K771479", "K830160", "K051629", "K854213", "K981845", "K901117", "K851621", "K971030", "K060193", "K092864", "K000706", "K800801", "K864806", "K123125", "K864447", "K983635", "K062388", "K081941", "K090233", "K790456", "K791530", "K864590", "K803052", "K213867", "K001988", "K923519", "K112722", "K050626", "K122063", "K862831", "K050676", "K905635", "K981530", "K101439", "K980553", "K030939", "K131790", "K120075", "K042419", "K061609", "K864589", "K040743", "K801100", "K050055", "K011404", "K901119", "K946127", "K151954", "K050883", "K102182", "K133958", "K071142", "K993410", "K903135", "K945234", "K923172", "K925580", "K934669", "K855022", "K080175", "K844563", "K000995", "K012446", "K071097", "K102389", "K771989", "K830680", "K833151", "K072884" ], "registration_number": [ "", "1530958", "3005783425", "1066427", "3009156722", "9710602", "2112667", "8043316", "9610531", "3003589956", "9617604", "3007603826", "1000122786", "3016618143", "3001104093", "3005803793", "2518157", "2221819", "1066270", "3010157426", "9611500", "3010703925", "8010042", "3007238566", "9611295", "3035111606", "3013188547", "3009129579", "1054713", "3021559257", "3000126629", "3022543477", "3014579161", "2020813" ], "fei_number": [ "", "3005783425", "3009156722", "3003513129", "2112667", "3023530182", "3003589956", "3007603826", "1000122786", "3016618143", "3001104093", "3005803793", "3002807907", "3003319165", "2518157", "2221819", "1000114111", "1000639866", "3000957797", "3010157426", "3002807992", "3010703925", "3002558692", "3007238566", "3035111606", "3013188547", "3007513035", "3009129579", "3021559257", "3000126629", "3022543477", "3002808128", "3014579161", "2020813" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }