Fresenius Medical Care Holdings, Inc. Recall 90367
Description: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Fresenius Medical Care Holdings, Inc. Recall 90367 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1303-2022 |
| Event ID | 90367 |
| Event Description | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Pennsylvania. |
| Quantity | 19 cases |
| Recall Reason | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. |
| Device Classification | 20220706 |
| Device Code Info | UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017 |
| Center Classification Date | 20220630 |
| Recall Initiation Date | 20220504 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Similar To |