Official recall notice
FDA DeviceClass IINotable
FDA Recall: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- 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 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525