Z-3084-2026 Class II Ongoing
FDA device recall Z-3084-2026 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: 120 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
- 120 units
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.
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 25KR01227 25NR01257 UDI-DI 00840861102556