medical Class II Updated 2025-03-12

Kung Shin Plastics Co. Ltd. recalls CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalo

Recalled Product

CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

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)00810050853682(10)C2N24002(11)240828(17)290827 Lot C2N24002
View official government recall

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