Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate for Bicarbonate Hemodialysis due to reports 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a cosmetic defect (discoloration) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is voluntarily recalling specific lots of NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis. The recall is being conducted due to complaints regarding blue-green discoloration in the product.
The affected product is distributed worldwide, including the United States and Mexico. The recall involves 2,998 cases and 68 individual units across seven product numbers. Specific lot numbers are listed in the official recall documentation.
Healthcare facilities and consumers should stop using the affected product and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- Hazard
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 (20)
- 1) 08-1251-1
- UDI/DI 00840861101658
- Lot Numbers: 26AXAC056
- 2) 08-2251-0
- UDI/DI 00840861101696
- Lot Numbers: 26AXAC050
- 26BXAC012
- 26BXAC042
- 3) 08-2301-3
- UDI/DI 00840861101702
- Lot Numbers: 26BXAC013
- 26BXAC045
- 3) 08-3251-9
- UDI/DI 00840861101740
- Lot Numbers: 26AXAC051
- 26BXAC011
- 26BXAC043
- 4) 08-3301-2
- UDI/DI 00840861101757
- Lot Numbers: 26AXAC052
Distribution
Distributed nationwide across the United States.
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