{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "221852", "product_res_number": "Z-3084-2026", "event_date_initiated": "2026-08-10", "event_date_posted": "2026-09-02", "recall_status": "Open, Classified", "res_event_number": "99556", "product_code": "KOC", "k_numbers": [ "K243505" ], "product_description": "5008X Standard HD Pre-Flush \r\nStandard Blood Tubing Set\r\n\r\nPart Number 03-5110-6", "code_info": "Lots 25KR01227\n25NR01257\n\nUDI-DI 00840861102556", "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": "Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.", "root_cause_description": "Component change control", "action": "On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters.\n\nCustomers were instructed to\n\n1. Identify any affected product on hand.\n2. IMMEDIATELY segregate and discontinue use of affected lot.\n3. Contact the call center at 1-888-943-4901 and reference Event 8514, between\n8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your\nstock.\n4, Complete and return the included reply form.", "product_quantity": "120 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.", "openfda": { "k_number": [ "K830183", "K831376", "K760629", "K811457", "K082758", "K760935", "K801356", "K840654", "K770044", "K831663", "K002372", "K010268", "K911106", "K840146", "K770046", "K830231", "K760625", "K983707", "K920614", "K912374", "K770691", "K822338", "K843632", "K822049", "K823068", "K760630", "K812498", "K833503", "K760627", "K832666", "K896006", "K761082", "K811977", "K935958", "K831433", "K832252", "K760640", "K791411", "K952572", "K830291", "K082719", "K895244", "K790591", "K832894", "K141997", "K971860", "K832053", "K833905", "K152953", "K840845", "K022536", "K954676", "K020103", "K842436", "K925522", "K760639", "K823707", "K941803", "K770383", "K242176", "K831482", "K833906", "K770045", "K926374", "K141281", "K160749", "K832103", "K831338", "K840937", "K833150", "K823546", "K761081", "K831606", "K924436", "K801354", "K821495", "K071909", "K822738", "K822283", "K770482", "K760638", "K844185", "K843531", "K832623", "K902588", "K920671", "K894637", "K844504", "K831409", "K242479", "K770048", "K770213", "K003712", "K913361", "K760628", "K172238", "K833308", "K770475", "K972206", "K230514", "K955277", "K840859", "K831175", "K810480", "K823839", "K830905", "K770382", "K121599", "K910321", "K822796", "K833653", "K840057", "K761078", "K831173", "K823826", "K964041", "K911315", "K911230", "K831770", "K790841", "K821367", "K941851", "K822226", "K810074", "K770552", "K831176", "K841124", "K833252", "K822339", "K832925", "K231589", "K761038", "K822337", "K994306", "K770524", "K760042", "K760633", "K201207", "K833440", "K823375", "K900306", "K895882", "K823733", "K840062", "K792277", "K781050", "K770043", "K823715", "K852134", "K853555", "K950282", "K910641", "K760631", "K833896", "K830729", "K760994", "K852135", "K823778", "K822225", "K760632", "K913483", "K760626", "K030456", "K941543", "K760637", "K760665", "K081740", "K081043", "K925654", "K822340", "K823069", "K834596", "K822244", "K831174", "K771424", "K811981", "K790381", "K801355", "K830021", "K002816", "K761051", "K823791" ], "device_name": "Accessories, Blood Circuit, Hemodialysis", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2", "registration_number": [ "1643817", "2029275", "3014638255", "8031561", "2032112", "3006755813", "3017636737", "9680579", "3013557562", "3038195011", "1625519", "3033903155", "1225714", "9611823", "8041145", "3015335038", "3004202080", "3003464075", "3005987240", "3030446844", "3043014136", "9617473", "1056186", "3005578748", "3006849754", "3035708507", "1644312", "1018470", "3005162618", "1649518", "1720929", "9611824", "2020550", "3000247873", "3012494290", "3014936217", "9616074", "3043226252", "1650907", "3016096143", "3008252904", "3027859369", "8030665", "3018348", "3023981687", "1424263", "1625425", "3004111573", "3010202439", "1932668" ], "fei_number": [ "1643817", "3014638255", "3002681132", "3006755813", "3003076831", "3017636737", "3001451489", "1000132332", "3002806960", "3013557562", "3038195011", "1625519", "3033903155", "3002807721", "3015335038", "3002807744", "3003464075", "3001733054", "3030446844", "3043014136", "3002807005", "3005987240", "1000126788", "3003015552", "1527681", "1000203464", "3005578748", "3006849754", "1000138417", "1000306431", "3001236277", "3035708507", "1018470", "3002654698", "1720929", "2020550", "3012494290", "3000247873", "3007475226", "3014936217", "3043226252", "3027859369", "3016096143", "3008730267", "3002974635", "1000117748", "3018348", "1625425", "3004111573", "3008252904" ] } } ] }