Recall Z-3085-2026 ยท KOC Accessories, Blood Circuit, Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
| Date | Sep 2, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| Reason | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. |
| Root cause | Component change control |
| Action | On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to 1. Identify any affected product on hand. 2. IMMEDIATELY segregate and discontinue use of affected lot. 3. Contact the call center at 1-888-943-4901 and reference Event 8514, between 8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your stock. 4, Complete and return the included reply form. |
| Quantity | 62,544 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243505 | 5008X Hemodialysis System Fresenius Medical Care Renal Therapies Group, LLC, May 30, 2025 |