Recall Z-0333-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care North America
Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N
| Date | Dec 31, 2005 (initiated Nov 28, 2005) |
| Status | Terminated |
| Reason | Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR |
| Root cause | Other |
| Action | Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002277 | FRESENIUS OPTIFLUX 200NR Fresenius Medical Care North America, Aug 25, 2000 |