FDA Enforcement
Class I
Ongoing
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Recall: Z-1801-2026
·
Reported April 22, 2026
Enforcement
- Recall Number
- Z-1801-2026
- Event ID
- 98552
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 22, 2026
- Initiation Date
- March 19, 2026
- Classification Date
- April 15, 2026
- Address
- 824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States
Description
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.
Code Info
Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
328,640 units