Medical Device

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Recall date: 2026-09-09 · Source: FDA_DEVICE

Brand / Firm

Fresenius Medical Care Renal Therapies Group, LLC

Product

Reason for recall

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.

Units affected

6,624 units

Description

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

View official recall notice →