BEUDAMED
    FDA Enforcement Class II Terminated

    CIRCUMCISION TRAY

    Recall: Z-1082-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1082-2018
    Event ID
    79329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    October 23, 2017
    Classification Date
    March 17, 2018
    Termination Date
    June 21, 2018
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    CIRCUMCISION TRAY

    Reason

    Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

    Code Info

    CIT6020 CIT6120 Lot codes: 2015081790 2015112090 2016011190 2016022390 2016031690 2016042690 2016061590 2016080890 2016090690 2016100790 2017010990 2017020990 2017040490 2017051590 2017061690 2015111390 2016012190 2016022390 2016033190 2016060690 2016071890 2016092290 2016111590 2017020990 2017030790 2017041390 2017051590

    Distribution

    Nationally

    Quantity

    N/A