Z-1801-2026 Class I Ongoing
FDA device recall Z-1801-2026 was initiated by B Braun Medical Inc on Mar 19, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 328,640 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2026
- Initiation Date
- Mar 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.