FDA-Device2026-04-22Class IPROCESSING DEFECT
B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
What this means
B. Braun Medical Inc is recalling certain hemodialysis bloodlines (model SL-2000M2095L) because small air bubbles can collect in the arterial line when the tubing is under negative pressure. This happens because blood gases stick to the inside of the tubing. No injuries have been reported.
- Stop using affected bloodline units immediately if you have them.
- Contact your hemodialysis center or B. Braun Medical Inc to confirm if your equipment is affected.
- Do not use model SL-2000M2095L manufactured on or after June 29, 2025.
- Return or dispose of recalled units as instructed by your provider or manufacturer.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
328,640 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1801-2026More B. Braun recalls
- FDA-Device2026-09-09B Braun Discofix Four Way Stopcock recalled for incorrect expiration date
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