FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius 5008X Standard HD blood tubing set recalled for blood leak risk
What this means
Fresenius Medical Care is recalling certain 5008X Standard HD Pre-Flush blood tubing sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line. A leak during dialysis treatment could result in blood loss.
- Check your tubing set lot number (25KR01227 or 25NR01257) against your records or contact your dialysis center.
- If you have an affected set, do not use it and notify your healthcare provider or dialysis facility immediately.
- Your dialysis center will provide a replacement tubing set.
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
120 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3084-2026More 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 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
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