Official recall notice
FDA DeviceClass IINotable
FDA Recall: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Recall date
- 2026-09-09
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518