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 | Potential for external blood leaks from the dialyzer header |
| Product | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E |
| Quantity | 9,097 cs x 12 units each |
| Distribution | US Nationwide |
| Initiated | 2018-11-05 |
| Classified | 2018-12-20 |
| Terminated | 2023-04-17 |
| Recall number | Z-0658-2019 |
| 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 II recall — Fresenius Medical Care Renal Therapies Group, LLC (Z-0658-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81598/
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