Fresenius recalls 5008X dialysis blood tubing sets over risk of blood leak at a connection
The connection between the Arterial Alpha Clip and the main line or pump segment is more likely to leak, and a leak during treatment may cause blood loss and low blood volume (hypovolemia).
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8; 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6; 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- 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.
- Units
- 6,624 units; 120 units; 62,544 units
- Where sold
- 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.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- September 2, 2026
- Recall started
- August 10, 2026
- FDA enforcement report
- September 9, 2026
- Identifiers
- Codes: Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
- FDA recall number: Z-3087-2026
- Codes: Lots 25KR01227 25NR01257 UDI-DI 00840861102556
- FDA recall number: Z-3084-2026
- Codes: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
- FDA recall number: Z-3085-2026
- Codes: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
- FDA recall number: Z-3086-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
- Reason for recall
- 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 (Ongoing)
- 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.
- Quantity
- 6,624 units; 120 units; 62,544 units; 18,600
Related recalls
Fresenius Medical Care recalls CombiSet Hemodialysis Blood Tubing Sets and asks users to review instructions for use
The notice recommends reviewing the instructions for use (IFU) and making sure all treatment preparation and handling steps are performed as instructed for the CombiSet Hemodialysis Blood Tubing Set, model 03-2522-1.
Fresenius Medical Care Renal Therapies Group, LLC · 1743026 units
Fresenius recalls 2008T BlueStar hemodialysis machines over flow, no-water and temperature alarms
The company received complaints that these dialysis machines set off alarms for flow problems, no water or temperature problems, and the notice covers 1140 systems sold across the US.
Fresenius Medical Care Renal Therapies Group, LLC · 1140 systems