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Kung Shin Plastics Co. Ltd. recalls CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/C
Recalled March 12, 2025 · FDA recall Z-1268-2025 · Kung Shin Plastics
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. · FDA Class II
Units
50000 ea/ 500 cases
Sold at
US Nationwide distribution in the state of IL.
Description
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.
Product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Manufacturer(s)
Kung Shin Plastics Co. Ltd.
Made in
Taiwan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →