BEUDAMED
    FDA Enforcement Class III Terminated

    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

    Recall: Z-0105-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0105-2016
    Event ID
    72107
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    September 1, 2015
    Classification Date
    October 6, 2015
    Termination Date
    January 29, 2016
    Address
    75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

    Reason

    Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

    Code Info

    LOT 187889

    Distribution

    US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.

    Quantity

    305 units