B. Barun Hemodialysis Bloodlines recall (B Braun Medical Inc)
Medical deviceClass IOngoing
Summary: B Braun Medical Inc is recalling B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.. Reason: Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
What is being recalled
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Why
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
How to tell if yours is affected
Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1801-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | March 19, 2026 |
| Reported | April 22, 2026 |
| Company | B Braun Medical Inc |
| Company location | Bethlehem, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 328,640 units |
More recalls from B Braun Medical Inc · all medical device recalls · recalls from March 2026