Class IIDeviceOngoing

Fresenius Medical Care Renal Therapies Group, LLC

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

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.

Details

Recall number: Z-3087-2026
Event ID: 99556
Recall initiated: Aug 10, 2026
Classified: Sep 2, 2026
Reported: Sep 9, 2026
Quantity: 6,624 units
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
Initiated by: Voluntary: Firm initiated
Firm notification: N/A
Firm location: Waltham, MA, United States
Lot / code info: Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525