Recall Z-1992-2025 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
| Date | Jun 18, 2025 (initiated Apr 29, 2025) |
| Status | Open, Classified |
| Reason | Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration. |
| Root cause | Process control |
| Action | Fresenius Medical Care notified its single consignee on 04/29/2025 via telephone call. The consignee was made aware of the issue and affected units and instructed to examine their inventory for those affected units. If they had any affected units, they were instructed to remove them from their inventory immediately and provide contact information to arrange for their return. On 05/14/2025, Fresenius Medical Care expanded the recall to include additional lot numbers and notified consignees. The notification was via telephone call and included the same instructions as the initial letter but in |
| Quantity | Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192) |
| Distribution | US Nationwide distribution in the state of Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231534 | 5008X Hemodialysis System Fresenius Medical Care, Feb 2, 2024 |