BEUDAMED
    FDA Enforcement Class II Ongoing

    COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

    Recall: Z-0955-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0955-2023
    Event ID
    91318
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 18, 2023
    Initiation Date
    November 23, 2022
    Classification Date
    January 12, 2023
    Address
    161 Cheshire Ln N Ste 100, Minneapolis, MN, 55441-5433, United States

    Description

    COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

    Reason

    The product is labeled with the incorrect expiration date.

    Code Info

    UDI/DI (GTIN): 10884521825765, Lot Number: 520200

    Distribution

    Foreign Distribution: Hong Kong

    Quantity

    21 units