Dialysis concentrate labeling error for chemical composition
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
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: FDA Class II recall of a medical device involving a labeling error in chemical composition. No illnesses or injuries have been reported, and the actual product formulation is correct. Classification as 'moderate' reflects that this is a minor labeling error with no direct product safety hazard.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, used in dialysis treatment. The recall affects approximately 17,700 units distributed domestically.
The label's "Nominal Chemical Composition" section contains an error: it lists 5.62g/L potassium chloride (KCL), but this measurement actually corresponds to the calcium chloride (CaCl) content in the product. The actual product formulation is correct and remains potassium-free as intended.
Affected lot numbers include 20LTAC076, 20PTAC094, 21ATAC046, 21BTAC082, 21CTAC029, 21KTAC072, 21PTAC023, 21STAC094, and 22DTAC036. The product was distributed domestically to AL, AZ, CA, DC, FL, GA, HI, IL, IN, MD, MI, MO, MS, NE, NJ, NY, OH, PA, SD, TX, and VA.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 17,700
Distribution
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