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

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 328,640 units Lot/code info: Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.

UPC codes

04046955348909, 04046955348893

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.