BEUDAMED
    FDA Enforcement Class II 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 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1053-2013
    Event ID
    64528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    February 26, 2013
    Classification Date
    April 3, 2013
    Termination Date
    June 12, 2014
    Address
    75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    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).

    Code Info

    Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13

    Distribution

    Nationwide Distribution including Puerto Rico

    Quantity

    4395 kits