Recall Z-1303-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
| Date | May 4, 2022 |
| Status | Terminated |
| Reason | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. |
| Root cause | Under Investigation by firm |
| Action | A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory. |
| Quantity | 19 cases |
| Distribution | US Nationwide distribution in the state of Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162488 | Optiflux dialyzer Fresenius Medical Care North America, Apr 6, 2017 |