Recall Z-1866-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
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 | 45,880 components |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.