Recall Z-3225-2026 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Fresenius Medical Care Renal Therapies Group, LLC
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
| Date | Sep 18, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| Reason | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. |
| Root cause | Use error |
| Action | On July 30, 2026 IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers. Letter provides information and instructions on the use of the device. As part of routine best practice, we recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. There are potential risks to patient health that are associated with blood loss, treatment delay, or air entering the system. Ensure all steps of the IFU are followed, that the Transducer Protector connection to the bloodline monitor line is tight, and that the transducer protector and |
| Quantity | 1743026 units |
| Distribution | Domestic: Nationwide Distribution; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213992 | CombiSet Hemodialysis Blood Tubing Set Fresenius Medical Care Renal Therapies Group, LLC, May 31, 2023 |