Recall Z-1870-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
| Date | May 17, 2024 (initiated Apr 17, 2024) |
| Status | Open, Classified |
| Reason | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. |
| Root cause | Device Design |
| Action | On April 17, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer actions: As per the 2008T Operators Manual P/N 490122 Rev AA: Blood Pump Rotors should be inspected for proper operation, as stated in Chapter 2: Daily preparation for treatment. If you experience a dislodged guide post sleeve, bent or loose tubing guide posts, or roller cannot move freely on your current F40015481 Rev A blood pump rotor, please contact FMCRTG Technical Support Services at 800-405-1321 for a replacement Blood Pump Rotor (Part Number, F40015481, Rev C) . Have Rotor Lot Number availab |
| Quantity | 11,371 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 |
| K222952 | 2008T BlueStar Hemodailysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Oct 27, 2022 |
| K231125 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, Dec 6, 2023 |