BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1268-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1268-2025
    Event ID
    96224
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Kung Shin Plastics Co. Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 12, 2025
    Initiation Date
    January 9, 2025
    Classification Date
    March 4, 2025
    Address
    65-2 Erh Chia Road, Ying Kuo Town, Taipei Hsien, N/A, Taiwan

    Description

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

    Reason

    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.

    Code Info

    UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    50000 ea/ 500 cases