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 | Dialyzer header leak due to possible improper torque |
| Product | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis |
| Quantity | 1,650 units |
| Distribution | US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA. |
| Initiated | 2016-02-26 |
| Classified | 2016-04-05 |
| Terminated | 2017-06-26 |
| Recall number | Z-1324-2016 |
| 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-1324-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73387/
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