{ "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": "169729", "product_res_number": "Z-0759-2019", "event_date_initiated": "2018-09-06", "event_date_created": "2019-01-23", "recall_status": "Terminated", "event_date_terminated": "2020-05-13", "res_event_number": "81755", "product_code": "KOC", "k_numbers": [ "K082758" ], "product_description": "Heating Profile PRISMAFLO II S blood return warmer for Prismaflex\nProduct Code: PF2-WP33\n\nProduct Usage:\nThe PRISMAFLO IIS warmer is used for warming return blood flow.", "code_info": "Serial Numbers: E22000 to E23999", "firm_fei_number": "3001733054", "recalling_firm": "Stihler Electronic Gmbh", "address_1": "Julius-Holder-Str. 36 36 julius-holder-str.", "city": "Stuttgart", "country": "Germany", "reason_for_recall": "PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn", "root_cause_description": "Device Design", "action": "STIHLER ELECTRONIC GMBH notified distributors by Registered mail/email and to Head of Biomedical on 09/06/18 identifying the problem, health risk and action to be taken: identify the Heating Profiles according to the serial numbers specified. These profiles must be replaced based on your accurate reply. Complete Inventory must be accounted for. For your reply use attached \"Return Form\" to Stihler Electronic GmbH. Send the filled return form via e-mail to nicola. vosseler@sti hlerelectronic. de. 3. You will receive the replacement Heating Profiles from our distributor Futuremed America Inc., 15700 Devonshire Street, Granada Hills,\n91344 California, US.", "product_quantity": "821", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland", "openfda": { "k_number": [ "K760633", "K020103", "K811981", "K760042", "K831433", "K895882", "K823707", "K792277", "K840057", "K152953", "K791411", "K911315", "K832925", "K770475", "K913483", "K823778", "K770383", "K994306", "K902588", "K840937", "K771424", "K822338", "K811977", "K972206", "K760626", "K810480", "K925522", "K823733", "K172238", "K160749", "K790841", "K242176", "K831482", "K823791", "K920614", "K910321", "K831606", "K141997", "K941803", "K770045", "K770048", "K790381", "K812498", "K913361", "K954676", "K896006", "K926374", "K831409", "K770382", "K823839", "K841124", "K790591", "K823715", "K830905", "K242479", "K842436", "K822339", "K831376", "K823069", "K912374", "K121599", "K760935", "K831176", "K941543", "K935958", "K925654", "K781050", "K831173", "K002816", "K823375", "K010268", "K811457", "K833252", "K924436", "K852135", "K830183", "K761051", "K830729", "K834596", "K821367", "K955277", "K832666", "K822337", "K964041", "K831338", "K760639", "K950282", "K821495", "K822225", "K843531", "K082719", "K832252", "K760638", "K760640", "K770552", "K760629", "K910641", "K081740", "K983707", "K823068", "K761038", "K833906", "K770213", "K833150", "K941851", "K840146", "K760625", "K831770", "K844185", "K770044", "K833905", "K833440", "K840654", "K760637", "K760631", "K900306", "K895244", "K770046", "K840859", "K823546", "K843632", "K761081", "K230514", "K840845", "K830291", "K832103", "K832053", "K810074", "K761082", "K911106", "K920671", "K770043", "K830021", "K822226", "K003712", "K822244", "K071909", "K831174", "K833653", "K830231", "K822796", "K081043", "K822283", "K760628", "K911230", "K770482", "K760632", "K831175", "K832894", "K853555", "K201207", "K831663", "K971860", "K952572", "K760627", "K770691", "K761078", "K801355", "K760665", "K770524", "K832623", "K760994", "K833896", "K822340", "K002372", "K022536", "K823826", "K082758", "K822738", "K894637", "K030456", "K760630", "K844504", "K833308", "K822049", "K833503", "K801354", "K141281", "K840062", "K852134", "K801356", "K231589" ], "device_name": "Accessories, Blood Circuit, Hemodialysis", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2", "registration_number": [ "3027859369", "3033903155", "3010202439", "1018470", "3004111573", "3030446844", "1650907", "1649518", "3000247873", "1720929", "3004202080", "1056186", "1225714", "1932668", "3014638255", "9617473", "9616074", "3014936217", "1625519", "3016096143", "9680579", "1643817", "3015335038", "3043014136", "9611823", "3006849754", "2029275", "1625425", "3005987240", "2020550", "1644312", "3003464075", "3008252904", "8041145", "3006755813", "3012494290", "8030665", "3005578748", "3017636737", "8031561", "3023981687", "3038195011", "3018348", "3035708507", "3013557562", "1424263", "3005162618", "9611824", "3043226252", "2032112" ], "fei_number": [ "1000138417", "3027859369", "3033903155", "1000203464", "1018470", "3004111573", "1000306431", "3030446844", "1527681", "3002807721", "3000247873", "3002807005", "1720929", "3002681132", "3014638255", "3002974635", "3014936217", "1625519", "3016096143", "3001236277", "1643817", "3015335038", "3043014136", "3006849754", "2020550", "1625425", "3005987240", "3002807744", "3001451489", "1000132332", "3002654698", "3003464075", "3008252904", "1000117748", "3006755813", "3012494290", "3005578748", "3017636737", "3008730267", "3003015552", "3038195011", "3018348", "3035708507", "3007475226", "3013557562", "3002806960", "3001733054", "3003076831", "3043226252", "1000126788" ] } } ] }