Recall Z-1951-2010 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care North America
Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.
| Date | Jul 1, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | Hemodialyzer may leak at the header/end cap |
| Root cause | Process control |
| Action | Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product. |
| Quantity | 34,152 units |
| Distribution | Nationwide Distribution |
| 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 |