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Medical Device

5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

Recall date: 2026-09-09 · Source: FDA_DEVICE
Brand / Firm
Fresenius Medical Care Renal Therapies Group, LLC
Product
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
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
62,544 units
Description
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
View official recall notice →