FDA-Device2026-04-22Class I

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

B Braun Medical Inc
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
2,653,711 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1799-2026

Original summary

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Affected quantity: 2,653,711 units

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