{"url_path":"/fda/device/recalls/Z-3091-2026","section_key":"summary","section_title":"DEVICE Recall: Fresenius Medical Care Renal Therapies Group, LLC — GRANUFLO Dry Acid Concentrate:  Product Numbers:  0FD2251-3B; 0FD3251-3B; Dry 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-3091-2026%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":86,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3091-2026\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\nGRANUFLO Dry Acid Concentrate:  Product Numbers:  0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis\n\n## Reason\nComplaints of blue-green discoloration in product\n\n## Affected lots\n1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers:  26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009;  2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers:  26AXGF014, 26AXGF018.\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Mexico."}