United StatesB. Braun Hemodialysis Bloodlines are affected — identified by model numbers SL-2010M2096A, SL-2010M2096, SL-2000M2095DA, SL-2000M2095L, B3-3632M3705 and B3-4630M4705 (all lots manufactured since the dates listed in the notice and the corresponding UDI-DIs). They were recalled because of the potential for accumulation of small air bubbles in the arterial line from adherence of blood gases to the tubing under negative pressure. The products were distributed worldwide, including the United States and Canada.
What's being recalled
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Recalling firm: B Braun Medical Inc, Bethlehem, PA, United States.
How to identify it
Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025 Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025. Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025. Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025. Model Number: B3-3632M3705; UDI-DI Primary: 04046955348824; UDI-DI Unit: 04046955348817; All lots manufactured since 01AUG2025. Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.
The hazard
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)