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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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