Recall Z-2340-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
| Date | Jul 11, 2024 (initiated Jun 3, 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 | Component design/selection |
| Action | On June 3, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to consignees. Fresenius Medical Care is requesting replacement of affected Blood Pump Rotors in 2008K@HOME systems due to the patients possibly being unaware of this component failing. To order for a replacement Blood Pump Rotor (Part Number, F40015481), contact Fresenius Medical Care Customer Service at 800-227-2572, OPTION 3, o Please have Blood Pump Rotor Part Number and Lot Number available when requesting a replacement. CUSTOMER: 1. Please provide this letter to your Biomedical Technician. 2. Report any complaints or a |
| Quantity | 372 units |
| Distribution | Domestic: Nationwide Distribution. International: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.