Recall Z-3084-2026— Fresenius Medical Care Renal Therapies Group, LLC
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2026-08-10. It names one FDA 510(k) clearance: K243505. Product: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6. Reason: 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..
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-10
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.