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: 2,653,711 units Lot/code info: Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.
04046964367786, 04046964367779
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.