Optiflux F160NR Capillary High Flux Dialyzer Single Use Only — Class II medical device recall Z-0658-2019
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-12-26, distributed nationwide. Potential for external blood leaks from the dialyzer header
| Recall number | Z-0658-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2018-11-05 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2023-04-17 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | 18HU06016, 18HU06017, 18HU06018, 18HU06019 |
Product
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Reason for recall
Potential for external blood leaks from the dialyzer header
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0658-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.