Kung Shin Plastics Co. Ltd.: Device Recall

Recall #Z-1269-2025 · 01/09/2025

Class II: Risk

Recall Details

Recall Number: Z-1269-2025
Classification: Class II
Product Type: Device
Recalling Firm: Kung Shin Plastics Co. Ltd.
Status: Ongoing
Date Initiated: 01/09/2025
Location: Taipei Hsien, Taiwan
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30000 ea/ 300 cases

Reason for Recall

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 Description

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

Distribution Pattern

US Nationwide distribution in the state of IL.

Other Recalls by Kung Shin Plastics Co. Ltd.

Class II: Risk 01/09/2025

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.

View all recalls by Kung Shin Plastics Co. Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.