{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "75494", "product_res_number": "Z-0860-2009", "event_date_initiated": "2008-11-25", "event_date_posted": "2009-01-23", "recall_status": "Terminated", "event_date_terminated": "2009-09-24", "res_event_number": "50491", "product_code": "KOC", "k_numbers": [ "K022536" ], "product_description": "CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)\nProduct Code: 03-2794-0\n\nBonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device", "code_info": "Lot Numbers:  8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271.", "firm_fei_number": "3001451489", "recalling_firm": "Fresenius Medical Care North America", "address_1": "920 Winter St", "city": "Waltham", "state": "MA", "postal_code": "02451-1521", "additional_info_contact": "SAME\n800-662-1237", "reason_for_recall": "Port may crack and separate resulting in potential blood exposure/blood loss for the patient", "root_cause_description": "Process control", "action": "Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.", "product_quantity": "351,743 units", "distribution_pattern": "Worldwide Distribution --- including USA and country of Canada.", "openfda": { "k_number": [ "K833440", "K770213", "K242176", "K920614", "K831338", "K830291", "K822337", "K002816", "K760638", "K081740", "K823068", "K760633", "K840859", "K841124", "K954676", "K840654", "K972206", "K822225", "K071909", "K832666", "K020103", "K022536", "K822339", "K152953", "K910321", "K831606", "K760627", "K834596", "K770046", "K770552", "K141281", "K141997", "K823375", "K935958", "K833905", "K082719", "K822226", "K801355", "K823778", "K964041", "K770482", "K770475", "K811977", "K941543", "K913483", "K811457", "K821495", "K842436", "K832894", "K910641", "K994306", "K912374", "K082758", "K822283", "K832623", "K761082", "K955277", "K822738", "K822244", "K831173", "K832252", "K830183", "K770044", "K926374", "K852134", "K760935", "K840062", "K823069", "K895882", "K830729", "K760630", "K830905", "K830021", "K831482", "K823715", "K760640", "K832925", "K852135", "K911230", "K003712", "K913361", "K844185", "K081043", "K823707", "K896006", "K760665", "K823826", "K770382", "K230514", "K844504", "K895244", "K840057", "K760632", "K030456", "K760639", "K831433", "K761038", "K843531", "K760994", "K831376", "K894637", "K770383", "K812498", "K832053", "K760042", "K810480", "K833653", "K790381", "K925654", "K983707", "K770043", "K840845", "K924436", "K840937", "K833150", "K790841", "K822796", "K853555", "K760637", "K121599", "K925522", "K771424", "K823791", "K242479", "K831409", "K833503", "K761078", "K761051", "K840146", "K831174", "K911315", "K761081", "K822340", "K781050", "K010268", "K822338", "K911106", "K831175", "K811981", "K971860", "K833252", "K831770", "K770045", "K823839", "K821367", "K201207", "K760626", "K941851", "K760631", "K810074", "K902588", "K833896", "K792277", "K823546", "K831663", "K832103", "K770691", "K822049", "K760625", "K950282", "K900306", "K920671", "K160749", "K770048", "K760629", "K952572", "K760628", "K801354", "K941803", "K823733", "K002372", "K833308", "K172238", "K830231", "K790591", "K801356", "K843632", "K770524", "K831176", "K791411", "K231589", "K833906" ], "device_name": "Accessories, Blood Circuit, Hemodialysis", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2", "registration_number": [ "3005578748", "3014638255", "3003464075", "3033903155", "9611824", "8031561", "3006755813", "3018348", "3023981687", "8041145", "3012494290", "1720929", "3005987240", "1644312", "2029275", "1625519", "1643817", "2032112", "3006849754", "9680579", "1225714", "3043226252", "3035708507", "3004111573", "3014936217", "3004202080", "1056186", "3000247873", "3027859369", "3015335038", "3038195011", "1649518", "1424263", "3010202439", "9616074", "9617473", "1932668", "3030446844", "1018470", "3013557562", "8030665", "3043014136", "1650907", "2020550", "1625425", "3008252904", "3017636737", "9611823", "3005162618", "3016096143" ], "fei_number": [ "3002807005", "3005578748", "3014638255", "3003464075", "1000117748", "3033903155", "3003076831", "3006755813", "3018348", "3001236277", "3012494290", "1720929", "3005987240", "1000132332", "1625519", "1643817", "3002654698", "3006849754", "3007475226", "1000306431", "3002807744", "1000203464", "3043226252", "3035708507", "3004111573", "3002974635", "3002807721", "3014936217", "3000247873", "1000126788", "3027859369", "3015335038", "3003015552", "3038195011", "1000138417", "3001733054", "3030446844", "3008730267", "1018470", "1527681", "3002681132", "3013557562", "3043014136", "3002806960", "2020550", "1625425", "3008252904", "3017636737", "3016096143", "3001451489" ] } } ] }