TemporaryFDAOngoing
Can cause harm that is usually temporary.
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Check the device or its packaging for
Lots 25KR01227 25NR01257 UDI-DI 00840861102556
- Why
- 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.
- Distributed
- 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.
- Company
- Fresenius Medical Care Renal Therapies Group, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3084-2026 · retrieved 2 September 2026
Read the official notice