BEUDAMED
    FDA Enforcement Class II Ongoing

    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

    Recall: Z-1847-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1847-2022
    Event ID
    90793
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    August 16, 2022
    Classification Date
    September 28, 2022
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

    Reason

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

    Code Info

    TMT-35-145 G01677 UDI-DI: 00827002016774 Lot/Expiration Date: 14808818 22-06-2027

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    N/A