Class II — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. |
| Quantity | 17700 |
| Distribution | Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution. |
| Initiated | 2022-10-04 |
| Classified | 2022-11-04 |
| Recall number | Z-0181-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-0181-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90947/
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