Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the device is 0.4%. While no long-term adverse patient effects have been associated with this issue, potential risks include air embolism, thrombosis and foreign body in patient. Recall start date: Mar 11, 2022
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