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FDA-Device2026-04-22Class IPROCESSING DEFECT

B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis

B. Braun
OTHERNationwide distribution

Stop using B. Braun STREAMLINE BLOODLINE SET

B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG DR. (Model SL-2010M2096A) due to a potential risk of small air bubbles accumulating in the arterial line during hemodialysis treatment. This happens when blood gases stick to the tubing under negative pressure, which could affect treatment safety. The recall affects units manufactured on or after June 9, 2025.

  • Stop using Model SL-2010M2096A bloodline sets immediately
  • Contact B. Braun Medical Inc or your dialysis center for instructions on obtaining replacement bloodline sets
  • Check your dialysis facility's inventory and notify staff if you use this product
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.

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
3,158,104 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2026

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