NaturaLyte Liquid Acid concentrate — Class II medical device recall Z-0181-2023
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-11-16, distributed in AL, AZ, CA, DC, FL, GA, HI, IL…. The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.
| Recall number | Z-0181-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2022-10-04 |
| Classified | 2022-11-04 |
| Reported by FDA | 2022-11-16 |
| Distributed | AL, AZ, CA, DC, FL, GA, HI, IL, IN, MD, MI, MO, MS, NE, NJ, NY, OH, PA, SD, TX, VA |
| Quantity | 17,700 |
| Reason classes | chemical contamination, labeling |
| UPC / GTIN / UDI-DI | 00840861101610 |
| Lot numbers | 20LTAC076, 20PTAC094, 21ATAC046, 21BTAC082, 21CTAC029, 21KTAC072, 21PTAC023, 21STAC094, 22DTAC036 |
| Model numbers | 08-0231-4 |
Product
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Reason for recall
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0181-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.