Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Recalling company
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 10, 2026
- Reported
- Sep 9, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 6,624 units
- Lot / codes
- Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3087-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3087-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.