FDA-Device2025-10-29Class I
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Hazard
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Sold states
Domestic: US Nationwide Distribution.
Affected count
1298454 units (1589674 - 3/5/26 Expansion)
Manufactured in
861 Marcon Blvd, Allentown, PA, United States
Products
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2026More B BRAUN MEDICAL INC recalls
- FDA-Device2026-04-22B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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