Z-3091-2026 Class II Ongoing
FDA device recall Z-3091-2026 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on July 14, 2026 and is designated Class II. Reason for recall: Complaints of blue-green discoloration in product The recall status is ongoing. Affected quantity: 27,216 cs; 2,316 ea.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,216 cs; 2,316 ea
Product Description
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Reason for Recall
Complaints of blue-green discoloration in product
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Mexico.
Code Information
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.