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 | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
| Product | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. |
| Quantity | 918 units |
| Distribution | Nationwide Distribution. |
| Initiated | 2015-10-23 |
| Classified | 2015-11-18 |
| Terminated | 2021-03-02 |
| Recall number | Z-0294-2016 |
| 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-0294-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72484/
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