Fresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to complaints of blue-green discoloration in the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (hemodialysis concentrate) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling specific lots of GRANUFLO Dry Acid Concentrate used for bicarbonate hemodialysis. The recall involves product numbers 0FD2251-3B and 0FD3251-3B, with a total quantity of 27,216 cases and 2,316 individual units. The affected lots include 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009, 26AXGF014, and 26AXGF018.
The recall was initiated due to complaints regarding blue-green discoloration in the product. The agency has classified this as a Class II recall. The product was distributed worldwide, including nationwide in the United States and in Mexico.
Healthcare providers and patients should check their inventory for the specific lot numbers and product numbers listed above. If the product is found, it should be stopped from use and returned to the manufacturer or disposed of according to local regulations. Consumers should contact their healthcare provider for further instructions.
The recalled product
- Product
- GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 1) 0FD2251-3B
- UDI/DI 00840861101535
- Lot Numbers: 26AXGF015
- 26AXGF016
- 26AXGF017
- 26BXGF008
- 26BXGF009
- 2) 0FD3251-3B
- UDI/DI 00840861101597
- Lot Numbers: 26AXGF014
- 26AXGF018.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak
FDA (Devices) · 2026-09-09