Device product
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Z-1801-2026
Product summary
- Event
- Event 98552
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 328,640 units
- Official record key
device-enforcement:Z-1801-2026
Official wording
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.
Code information: Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.