Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Potassium Concentration Error
Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate because some units in the affected lot had a potassium concentration of 2.25 mEq/L instead of the labeled 2.0 mEq/L.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The deviation in potassium concentration is a labeling and formulation discrepancy without reported injuries or illnesses in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 598 cases of NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0, 3.43 liter bottles. The product is a concentrate formulated for use with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in compatible 45X dilution three-stream artificial kidney (hemodialysis) machines.
The recall was initiated because the label specifies a potassium concentration of 2.0 mEq/L, but some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L. The affected lot is identified as Lot # 17KTAC076 with UDI-00840861101696.
The product was distributed in the United States to the states of California, Florida, Kansas, Louisiana, and Texas. Users of the product should stop using the affected lot and contact the recalling firm for further instructions.
The recalled product
- Product
- NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney…
- Affected units
- 598
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 (2)
- Lot # 17KTAC076
- UDI-00840861101696
Distribution
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