Class II — Fresenius Medical Care Renal Therapies Group, LLC
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L. |
| Product | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis |
| Quantity | 848 (212 cases) |
| Distribution | US Distribution to states of: KS, LA, MS, OK, and TX. |
| Initiated | 2016-01-18 |
| Classified | 2016-02-25 |
| Terminated | 2017-08-14 |
| Recall number | Z-0887-2016 |
| 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 Renal Therapies Group, LLC (Z-0887-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73077/
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