Kung Shin Plastics Co. Ltd.: CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

Hazard

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.

Details from the source

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: 50000 ea/ 500 cases Lot/code info: UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002

UPC codes

00810050852210

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.