Recall Z-0738-2008 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care North America
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
| Date | Feb 1, 2008 (initiated Dec 3, 2007) |
| Status | Terminated |
| Reason | Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss. |
| Root cause | Process control |
| Action | Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius. |
| Quantity | 2,791 cases (33,492 dialyzers) |
| Distribution | Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI. |
| 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 |