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: 1,174,271 units Lot/code info: Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.
04046955776023, 04046955776016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.