Recalling firm
B Braun Medical Inc
Product type
Device
Status
Ongoing
Report date
2026-04-22
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Firm state
PA
Product quantity
3,158,104 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Product description
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Code / lot info
Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.