Kung Shin Plastics Co. Ltd. recalls CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/…

Recall date

January 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1268-2025

FDA classification

Class II

Brand / firm

Kung Shin Plastics Co. Ltd.

Sold / distributed

US Nationwide distribution in the state of IL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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