FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk during dialysis
What this means
Fresenius Medical Care is recalling certain 5008X HD/HDF blood tubing sets (part number 03-5300-3C) due to a heightened risk of blood leaks at the connection between the Arterial Alpha Clip and the main line. Blood leaks during dialysis treatment can result in significant blood loss.
- Check if your dialysis clinic uses the affected tubing sets (part number 03-5300-3C, lots 25JR01801, 25KR01225, 25KR01251, 25NR01016, or 25NR01265).
- Contact your dialysis provider or Fresenius immediately if you have questions about your tubing sets.
- Do not use affected tubing sets; follow your clinic's instructions for replacement or corrective action.
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
18,600
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3086-2026More Fresenius Medical Care recalls
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk
- 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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