Class III — 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 III |
| Status | Terminated |
| Reason | Discolored powder has confirmed the presence of a foreign substance |
| Product | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis |
| Quantity | 22320 |
| Distribution | Distribution US nationwide and Mexico |
| Initiated | 2018-10-09 |
| Classified | 2018-11-29 |
| Terminated | 2021-08-05 |
| Recall number | Z-0518-2019 |
| 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 III recall — Fresenius Medical Care Renal Therapies Group, LLC (Z-0518-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81451/
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