{"url_path":"/fda/device/recalls/Z-3092-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Medical Care Renal Therapies Group, LLC — NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis:  Product Numbers:  08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-14","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3092-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Fresenius Medical Care Renal Therapies Group, LLC"},"word_count":148,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3092-2026\n\n**Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-14\n**Report date:** 2026-09-09\n\n## Product\nNaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis:  Product Numbers:  08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis\n\n## Reason\nComplaints of blue-green discoloration in product\n\n## Affected lots\n1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers:  26AXAC056;  2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers:  26AXAC050, 26BXAC012, 26BXAC042;  3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers:  26BXAC013, 26BXAC045;  3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers:  26AXAC051, 26BXAC011, 26BXAC043;  4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers:  26AXAC052;  5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers:  26AXAC062, 26AXAC064;  6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers:  26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051;   7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers:  26BXAC037, 26BXAC048.\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Mexico."}