FDA Device recall Z-1303-2022
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E by Fresenius Medical Care Holdings, citing dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1303-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-04 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Reason
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Identifiers
| code_info | UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2022%22
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