Fresenius Naturalyte Liquid Acid Concentrate Recalled for Labeling Error
Fresenius Medical Care is recalling Naturalyte Liquid Acid Concentrate because the label incorrectly lists the calcium concentration.
What this means for you
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 source text describes a labeling discrepancy regarding calcium concentration without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 848 units (212 cases) of Fresenius Naturalyte Liquid Acid Concentrate, Catalog Number 08-2301-3. The product is an acid concentrate intended for use in bicarbonate dialysis.
The recall is due to a labeling error on the product. The label incorrectly indicates that the product contains 2.5 mEq/L of calcium (Ca) in the right upper corner. The actual calcium concentration of the final dialysate, as indicated in the list of constituents, is 3.0 mEq/L.
The affected product is Lot Number 15STAC072 with an expiration date of 2017-12-31. Distribution was limited to the states of Kansas, Louisiana, Mississippi, Oklahoma, and Texas. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
- 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 (1)
- Lot Number: 15STAC072 Exp Date: 2017-12-31
Distribution
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