Recall Z-1278-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
| Date | Mar 20, 2018 (initiated Dec 14, 2017) |
| Status | Terminated |
| Reason | When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour. |
| Root cause | Device Design |
| Action | The recall notification instructs the user to the UF Goal with values less than 200ml when in Service Mode and to monitor and set the UF Rate to the desired setting after starting the SLED treatment. The consignee is advised that a software update is forthcoming to correct the issue. For further questions, please call (800) 227-2572. |
| Quantity | 127 |
| Distribution | US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153449 | 2008K2 Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Apr 26, 2016 |