Recall Z-0801-2025 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe
| Date | Jan 3, 2025 (initiated Dec 5, 2024) |
| Status | Open, Classified |
| Reason | Potential for internal blood leaks due to cracked polyurethane |
| Root cause | Process control |
| Action | Fresenius Medical Care notified consignees on about 12/05/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to stock immediately for either of the affected lot numbers, immediately discontinue use of Optiflux F160NRe Dialyzer(s) with lot codes, place any of the affected units in a secure, segregated area, arrange for return of affected product and complete and return the provided Reply Form. Additionally, consignees were instructed to forward the notification to any personnel within the organization or to customers where product was further distributed. |
| Quantity | 5,351 cases (64,212 dialyzers) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162488 | Optiflux dialyzer Fresenius Medical Care North America, Apr 6, 2017 |