Official recall notice
FDA DeviceClass INotable
FDA Recall: B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095
- Recall date
- 2026-04-22
- Brand
- B Braun Medical Inc
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
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.
Recommended action
What to do
328,640 units
Product description
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.