Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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: 3,158,104 units Lot/code info: Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
04046955674992, 04046955735280
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.