The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Reason for recall: The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications. Distribution: US Nationwide distribution in the state of IL. Quantity: 30000 ea/ 300 cases Lot/code info: UDI (01)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
00810050853682
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.