Recall Z-1618-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
| Date | May 13, 2014 (initiated Apr 25, 2014) |
| Status | Terminated |
| Reason | 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump |
| Root cause | Device Design |
| Action | Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572. |
| Quantity | 79 units |
| Distribution | USA (nationwide) and the country of Canada.* |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Dec 6, 2012 |