{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189151", "product_res_number": "Z-0456-2022", "event_date_initiated": "2021-11-24", "event_date_created": "2022-01-05", "recall_status": "Open, Classified", "res_event_number": "88641", "product_code": "KDI", "k_numbers": [ "K091978", "K152938" ], "product_description": "DBB-06 Hemodialysis Delivery System", "code_info": "Model Number: DBB-06; Serial Numbers: J1910861, J1905670, J1905916, J1910971, J1909943, J1909306, J1908111, J1909202, J1907127, J1908023, J1910962, J1910866, J1910028, J1909307, J1907329, J1909853, J1908776, J1908108, J1914585, J1908762, J1909020, J1908872, J1908439, J1908777, J1910867, J1911026, J1907034, J1911033, J1908665, J1909209, J1909705, J1906923, J1911029, J1910870, J1910967, 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Customers were instructed that the affected functions have been disabled on affected units and no actions need to be taken. Customers were asked to complete the provided response form and return it to the technical service when they visit each facility to complete the software update.\n\nQuestions can be directed to the firm at at 901-310-1567 option 1, Monday Friday, 9:00am-5:00pm CST, or by email at CS@nikkisomedical.us", "product_quantity": "781 units", "distribution_pattern": "Distributed nationwide to NY, MO, WA, CA, and TN.", "openfda": { "k_number": [ "K945595", "K933818", "K201809", "K153449", "K083460", "K841585", "K973516", "K931720", "K053539", "K240394", "K901286", "K890315", "K170469", "K170574", "K823338", "K093069", "K011269", "K811830", "K080650", "K853333", "K070320", "K232803", "K150880", "K230632", "K830648", "K193482", "K131516", "K840543", "K121409", "K062079", "K162248", "K926379", "K062922", "K140526", "K140866", "K870724", "K131050", "K113023", "K923312", "K040255", "K933883", "K160444", "K072232", "K150708", "K921134", "K864169", "K992894", "K982414", "K072093", "K171331", 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