FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk
What this means
Fresenius Medical Care is recalling certain 5008X HD/HDF Standard Blood Tubing Sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line or pump segment. A blood leak during dialysis treatment could result in blood loss and low blood volume.
- Check if your dialysis center uses the affected tubing (part number 03-5300-3, lots 25JR01800, 25KR01224, 25LR01001, 25NR01018, 25NR01272, 25PR01077, 25PR01219, or 25PR01220).
- Contact your dialysis provider or Fresenius for instructions on replacement or safe use of remaining stock.
- Report any blood leaks or injuries to Fresenius and the FDA.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
62,544 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3085-2026More Fresenius Medical Care recalls
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk during dialysis
- FDA-Device2026-09-09Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius GRANUFLO Dry Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius 5008X Standard HD blood tubing set recalled for blood leak risk
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