FDAFDA · Food and drugs·Recall number Z-3084-2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Published September 9, 2026 · Recall initiated: August 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Distributor
- 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.
- Lot
- Lots 25KR01227 25NR01257 UDI-DI 00840861102556
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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