Fresenius 5008X Blood Tubing Set
Fresenius recalls 5008X blood tubing set (PN 03-5110-6) over blood leak risk.
Stop using the affected blood tubing set immediately and contact Fresenius Medical Care Renal Therapies Group for instructions on returning the product and obtaining a replacement.
Why it was recalled
Fresenius Medical Care Renal Therapies Group is recalling the 5008X Standard HD Pre-Flush Standard Blood Tubing Set, Part Number 03-5110-6, due to a heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. A leak during treatment may lead to blood loss and hypovolemia.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | UDI-DI |
|---|---|---|
| 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C | 25JR01801, 25KR01225, 25KR01251, 25NR01016, 25NR01265 | 00840861102532 |
| 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | 25JR01802, 25NR01017, 25NR01266 | 00840861102525 |
| 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 | 25KR01227, 25NR01257 | 00840861102556 |
| 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | 25JR01800, 25KR01224, 25LR01001, 25NR01018, 25NR01272, 25PR01077, 25PR01219, 25PR01220 | 00840861102518 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Fresenius Medical Care Renal Therapies Group, LLC
All recalls from Fresenius Medical Care Renal Therapies Group, LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification