BEUDAMED
    FDA Recall Terminated

    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

    Recall: Z-1053-2013 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1053-2013
    Event Number
    64528
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 26, 2013
    Posted
    April 3, 2013
    Terminated
    June 12, 2014
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

    Reason

    LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).

    Action

    CooperSurgical sent a Recall Notification dated February 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CSI intends to track and quarantine returned product in a segregated location at its manufacturing facility to ensure its separation from acceptable product and prevent its misuse. CSI intends to render used product useless by physical destruction and to rework unused product by correcting the labeling for redistribution. If you have any one of these affected lot numbers in your current inventory, please contact our Customer Service Department at 800-243-2974, or simply complete the attached form and fax to 800-262-0105. Arrangements will be made to replace product in your possession at CooperSurgical's expense. Further instruction and disposition of product will be communicated to you at that time. CooperSurgical deeply regrets the inconvenience that this problem has caused.

    Distribution

    Nationwide Distribution including Puerto Rico

    Quantity

    4395 kits