BEUDAMED
    FDA Enforcement Class II Terminated

    GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

    Recall: Z-2280-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2280-2019
    Event ID
    83502
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2019
    Initiation Date
    May 16, 2019
    Classification Date
    August 15, 2019
    Termination Date
    June 4, 2020
    Address
    47709 Fremont Blvd, N/A, Fremont, CA, 94538-6512, United States

    Description

    GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

    Reason

    Incorrect coil length on the label

    Code Info

    Lot/Serial No: L14364 UDI:10886704080138

    Distribution

    Japan

    Quantity

    28 units