Optiflux 200NRe Dialyzer Finished Assy — Class II medical device recall Z-1303-2022
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2022-07-06, distributed nationwide. Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range i
| Recall number | Z-1303-2022 |
|---|---|
| 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 | 2022-05-04 |
| Classified | 2022-06-30 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2024-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 19 cases |
| UPC / GTIN / UDI-DI | 00840861100163 |
| Lot numbers | 22AU04017 |
| Model numbers | 0500320E |
Product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Reason for recall
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
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-1303-2022. 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.