Z-1801-2026 Class I Ongoing

Recalled by B Braun Medical Inc — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
April 22, 2026
Initiation Date
March 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
328,640 units

Product Description

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

Reason for Recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.