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Kung Shin Plastics Co. Ltd. recalls CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Recalled March 12, 2025 · FDA recall Z-1269-2025 · 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
30000 ea/ 300 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 Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Manufacturer(s)
Kung Shin Plastics Co. Ltd.
Made in
Taiwan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →