Z-3085-2026 Class II Ongoing
FDA device recall Z-3085-2026 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on August 10, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 62,544 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- August 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62,544 units
Product Description
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.
Distribution Pattern
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.
Code Information
Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518