Recall Z-1699-2019 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
| Date | Apr 3, 2019 |
| Status | Terminated |
| Reason | Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. |
| Root cause | Nonconforming Material/Component |
| Action | Fresenius issued An IMPORTANT MEDICAL DEVICE CORRECTION notification explains the problem, health risk and that a Fresenius Service Technician (FST) will be contacting them to schedule the correction. Questions, please contact Fresenius Technical Services at 800-227-2572. |
| Quantity | 257 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, May 10, 2018 |