BEUDAMED
    FDA Enforcement Class II Terminated

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    Recall: Z-1879-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1879-2018
    Event ID
    79828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 12, 2018
    Classification Date
    May 15, 2018
    Termination Date
    May 8, 2019
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    Reason

    Products have been packaged with an incorrect product size.

    Code Info

    Lot number: 212074

    Distribution

    CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

    Quantity

    500