Recall Z-1339-2012 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
| Date | Mar 30, 2012 (initiated Mar 6, 2012) |
| Status | Terminated |
| Reason | Risk of internal blood leaks affecting the hemodialyzers. |
| Root cause | Process control |
| Action | Fresenius North America notified consignees on 3/6/12 by recall notification letter titled:Urgent FMCNA Optiflux F160NRe Hemodialyzer Recall, by certified mail with return receipt. The letter identified the affected product and described the reason for the recall. Customers were instructed to examine their stock immediately to determine whether they have any of the affected lot on hand. If customers have the affected lot, they have been instructed to immediately discontinue use and place all unused units in a secure area for return to Fresenius Medical Care North America. A Reply Response |
| Quantity | 30,576 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003498 | FRESENIUS OPTIFLUX 200A Fresenius Medical Care North America, Jan 4, 2001 |