{ "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": 1 } }, "results": [ { "cfres_id": "221555", "product_res_number": "Z-3017-2026", "event_date_initiated": "2026-06-30", "event_date_posted": "2026-08-26", "recall_status": "Open, Classified", "res_event_number": "99438", "product_code": "KDI", "k_numbers": [ "K243237" ], "product_description": "Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.", "code_info": "191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5T0S291145, 5T0S291146, 5T0S291148, 5T0S291149, 5T0S291150, 5T0S291151, 5T0S291152, 5T0S291154, 5T0S291155, 5T0S291156, 5T0S291157, 5T0S291158, 5T0S291159, 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6T0S293111, 6T0S293112, 6T0S293114, 6T0S293115, 6T0S293116, 6T0S293117, 6T0S293118, 6T0S293119, 6T0S293120, 6T0S293121, 6T0S293122, 6T0S293123, 6T0S293124, 6T0S293125, 6T0S293126, 6T0S293127, 6T0S293128, 6T0S293129, 6T0S293131, 6T0S293132, 6T0S293133, 6T0S293134, 6T0S293135, 6T0S293136, 6T0S293137, 6T0S293138, 6T0S293139, 6T0S293140, 6T0S293141, 6T0S293142, 6T0S293144, 6T0S293145, 6T0S293146, 6T0S293147, 6T0S293148, 6T0S293190, 6T0S293191, 6T0S293198, 6T0S293200, 6T0S293311, 6T0S293317.", "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": "Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T\nBlueStar Hemodialysis machines.", "root_cause_description": "Process control", "action": "Fresenius Medical Care issued an URGENT MEDICAL DEVICDE CORRECTION notice to its consignees on 7/15/2026 via USPS First Class Mail. The notice explained the issue, potential risk and requested the following: \n\"What to do at this time: \n1. If your affected 2008T BlueStar machine is in use, and you are not experiencing error messages, you may continue to use it until the parts are replaced. \n2. If your affected 2008T BlueStar machine experiences flow-, no water-, or temperature-related alarms, please use a back-up machine until FMCRTG can replace the parts in the affected machine. \n3. If your affected 2008T BlueStar machine(s) has not yet been installed at your clinic, FMCRTG will replace the parts before installation. \nTo correct your machine(s), please contact FMCRTG Technical Service between 8:00 AM 5:00 PM Eastern daily, at 1-800-227-2572, and select Option 4, followed by Option 2, to be connected with the appropriate support representative to schedule your update, or if you have any further questions.\" \nFor any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.", "product_quantity": "1140 systems", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K953996", "K010805", "K914020", "K964922", "K250508", "K863961", "K233335", "K162488", "K920757", "K945596", "K890315", "K123395", "K872767", "K192756", "K212216", "K213639", "K861776", "K220281", "K014152", "K051187", "K911094", "K801303", "K823589", "K034064", "K140191", "K210575", "K193005", "K233557", "K233798", 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System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2" } } ] }