Recall Z-1026-2017 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008T Series Hemodialysis System
| Date | Dec 21, 2016 |
| Status | Terminated |
| Reason | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine |
| Root cause | Device Design |
| Action | Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form. |
| Quantity | 65361 units (US) 249 units (OUS) |
| Distribution | Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Dec 10, 2015 |