Optiflux F200NRe High Flux Dialyzers — Class II medical device recall Z-1102-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-03-05, distributed nationwide. Dialysate Port Leak During Priming of the Dialyzers
| Recall number | Z-1102-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2014-02-04 |
| Classified | 2014-02-26 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 317,796 units |
| Reason classes | packaging |
| Lot numbers | 13LU04021, 13LU04022, 13NU04003, 13NU04005, 13NU04018, 13SU04002 |
Product
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Reason for recall
Dialysate Port Leak During Priming of the Dialyzers
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-1102-2014. 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.