BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0105-2016 · Initiated September 1, 2015

    Recall

    Recall Number
    Z-0105-2016
    Event Number
    72107
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HEE
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 1, 2015
    Posted
    October 6, 2015
    Terminated
    January 29, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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%)

    Action

    CooperSurgical issued an "Recall Notification" dated September 1, 2015, to all affected customers via FedEX with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers asked to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for a free replacement. Contact Product Surveillance at 203.601.5200 ext. 3300

    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