B Braun Medical Inc: B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

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: 4,884 units Lot/code info: Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.

UPC codes

04046955348848, 04046955348831

Source

Official record: FDA (Device enforcement) ↗

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