{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222235", "product_res_number": "Z-3225-2026", "event_date_initiated": "2026-07-29", "event_date_posted": "2026-09-18", "recall_status": "Open, Classified", "res_event_number": "99700", "product_code": "FJK", "k_numbers": [ "K213992" ], "product_description": "CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;\nModel Number: 03-2522-1;", "code_info": "Model Number: 03-2522-1;\nUDI-DI: 00840861102402 (Bag), 10840861102409 (Case); \nLot codes: 26AR01010, 26BR01072, 26CR01067, 26DR01160, 26DR01198, 26AR01011, 26BR01074, 26CR01069, 26DR01161, 26DR01203, 26AR01034, 26BR01076, 26CR01070, 26DR01162, 26DR01206, 26AR01035, 26BR01077, 26CR01072, 26DR01163, 26DR01207,\n26AR01046, 26BR01078, 26CR01073, 26DR01165, 26DR01209, 26AR01047, 26BR01079, 26CR01074, 26DR01166, 26DR01210, 26AR01056, 26BR01082, 26CR01075, 26DR01167, 26DR01255, 26AR01057, 26BR01083, 26CR01076, 26DR01168, 26ER01022, 26AR01058, 26BR01084, 26CR01079, 26DR01170, 26ER01023, 26AR01059, 26BR01085, 26CR01080, 26DR01171, 26ER01024, 26AR01230, 26BR01087, 26CR01081, 26DR01172, 26ER01029,\n26BR01007, 26BR01088, 26CR01082, 26DR01173, 26ER01034, 26BR01035, 26BR01210, 26CR01083, 26DR01174, 26ER01035, 26BR01036, 26CR01014, 26CR01084, 26DR01175, 26ER01037, 26BR01037, 26CR01045, 26CR01085, 26DR01177, 26ER01039, 26BR01039, 26CR01046, 26CR01086, 26DR01180, 26ER01040, 26BR01045, 26CR01047, 26CR01087, 26DR01182, 26ER01042, 26BR01049, 26CR01048, 26CR01088, 26DR01183, 26ER01044,\n26BR01051, 26CR01049, 26CR01090, 26DR01184, 26ER01048, 26BR01052, 26CR01051, 26CR01091, 26DR01185, 26ER01049, 26BR01053, 26CR01052, 26CR01092, 26DR01186, 26ER01054, 26BR01057, 26CR01054, 26CR01093, 26DR01187, 26ER01055, 26BR01058, 26CR01056, 26CR01094, 26DR01188, 26ER01056, 26BR01059, 26CR01057, 26CR01206, 26DR01189, 26ER01062, 26BR01060, 26CR01058, 26CR01207, 26DR01190, 26ER01065,\n26BR01063, 26CR01059, 26CR01208, 26DR01191, 26ER01066, 26BR01064, 26CR01060, 26CR01209, 26DR01193, 26ER01074, 26BR01065, 26CR01061, 26CR01210, 26DR01194, 26ER01266, 26BR01066, 26CR01064, 26DR01013, 26DR01195, 26ER01268, 26BR01067, 26CR01065, 26DR01158, 26DR01196, 26ER01282, 26BR01069, 26CR01066, 26DR01159, 26DR01197;", "firm_fei_number": "3001451489", "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC", "address_1": "920 Winter St Bld 920", "city": "Waltham", "state": "MA", "postal_code": "02451-1521", "additional_info_contact": "Fresenius Medical Care Customer Service\n800-323-5188", "reason_for_recall": "Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.", "root_cause_description": "Use error", "action": "On July 30, 2026 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers. Letter provides information and instructions on the use of the device. As part of routine best practice, we recommend reviewing the IFU and ensuring that all treatment\npreparation and handling steps are performed as instructed. There are potential risks to patient health that are associated with blood loss, treatment\ndelay, or air entering the system. Ensure all steps of the IFU are followed, that the\nTransducer Protector connection to the bloodline monitor line is tight, and that the\ntransducer protector and female luer connections are finger tight to maintain a closed\nsystem.\nPlease contact FMCRTG Technical Service at 1-800-227-2572 if you have any further\nquestions. For any clinical or medical questions, please contact the Global Medical\nInformation and Education Office at 1-855-616-2309.", "product_quantity": "1743026 units", "distribution_pattern": "Domestic: Nationwide Distribution;", "openfda": { "k_number": [ "K243607", "K852605", "K090255", "K854271", "K992930", "K251442", "K864784", "K884243", "K853851", "K070414", "K780681", "K982340", "K063290", "K213992", "K001873", "K812685", "K810824", "K903021", "K962081", "K831424", "K161582", "K910558", "K852309", "K112628", "K873516", "K771693", "K012242", "K014140", "K901688", "K992039", "K820169", "K792054", "K100364", "K902426", "K952631", "K210782", "K001107", "K913526", "K830677", "K953823", "K801016", "K831747", "K920797", "K934803", "K251341", "K892932", "K080807", "K801211", "K802874", "K202796", "K971313", "K140841", "K811839", "K983559", "K032975", "K860740", "K201866", "K870722", "K810823", "K013634", "K921597", "K171952", "K792053", "K896407", "K950247", "K761326", "K851236", "K072024", "K252423", "K971687", "K120823", "K150304", "K821138", "K063293", "K000451", "K873455", "K853962" ], "device_name": "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2", "registration_number": [ "3005578748", "3035708507", "9616419", "2028411", "2024024", "8030639", "3006795797", "3013217742", "9611824", "2029275", "1018470", "3013671177", "3004530184", "3030446844", "9611823", "8030665", "3006755813", "2025816", "3008044552", "3043534762", "3013764800", "3014279513", "1056186", "9680579", "9614279", "3020689844", "3003589956", "2011171", "9610270", "3010291427", "3032828299", "3043014136", "3005246939", "3006849754", "9611369", "3016096143", "8030638", "3009746061", "1650907", "3042158867", "3010355846", "3015349756", "2032112", "3015335038", "3013536188", "3014936217", "3004960482", "3038138522", "9617594", "2032098", "3017636737", "1649518", "8041145", "3011163668", "3013546453", "2521402", "3017552925", "3044744771", "3000247873", "3004111573", "3032143970", "3010377171", "1225714", "3005162618", "3038195011" ], "fei_number": [ "3005578748", "3035708507", "3001451489", "3001236277", "2024024", "3006795797", "3013217742", "1018470", "3013671177", "3004530184", "3030446844", "3003767881", "6898", "3006755813", "1000125241", "1000132332", "3012394756", "2025816", "3008044552", "3002974635", "3043534762", "3013764800", "3002681132", "3014279513", "3020689844", "3003589956", "3038195011", "2011171", "1000306431", "3010291427", "3032828299", "3043014136", "3002807744", "3006849754", "3005246939", "1527681", "3016096143", "3009746061", "3042158867", "1000203464", "3010355846", "3015349756", "3015335038", "3002806960", "3013536188", "3014936217", "3004960482", "3038138522", "3003807466", "3017636737", "3002807005", "3011163668", "2521402", "3003076831", "3013546453", "3002807035", "3017552925", "3044744771", "3000247873", "3003656001", "3004111573", "3032143970", "3010377171", "3003058448", "3002806727" ] } } ] }