TemporaryFDAOngoing
Can cause harm that is usually temporary.
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Check the device or its packaging for
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
- Why
- Complaints of blue-green discoloration in product
- Distributed
- Worldwide distribution - US Nationwide and the country of Mexico.
- Company
- Fresenius Medical Care Renal Therapies Group, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3091-2026 · retrieved 3 September 2026
Read the official notice