medical Class II Updated 2025-03-12

Kung Shin Plastics Co. Ltd. recalls CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Ex

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002
View official government recall

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