FDA Device recall Z-1103-2014
Optiflux F200NR High Flux Dialyzers
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Optiflux F200NR High Flux Dialyzers by Fresenius Medical Care Holdings, citing dialysate Port Leak During Priming of the Dialyzers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1103-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-04 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Reason
Dialysate Port Leak During Priming of the Dialyzers
Identifiers
| code_info | Lot Number: 13NU04008 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.