FDA-Device2026-09-09Class IIPROCESSING DEFECT
Fresenius 5008X HD/HDF Twister Blood Tubing Set recalled for blood leak risk
What this means
Fresenius Medical Care is recalling specific lots of the 5008X HD/HDF Twister Blood Tubing Set (Part Number 03-5350-8) because the connection between the Arterial Alpha Clip and the main line may leak during dialysis treatment. A leak could result in blood loss and low blood volume.
- Check your dialysis tubing set for the affected lot numbers: 25JR01802, 25NR01017, or 25NR01266.
- Contact your dialysis center or Fresenius immediately if you have one of these lots.
- Do not use the affected 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
6,624 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3087-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.