BEUDAMED
    FDA Recall Terminated

    GENERAL PURPOSE INSTRUMENT TRAY

    Recall: Z-1080-2018 · Initiated October 23, 2017

    Recall

    Recall Number
    Z-1080-2018
    Event Number
    79329
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    LRP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 23, 2017
    Terminated
    June 21, 2018
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    GENERAL PURPOSE INSTRUMENT 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.

    Action

    On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.

    Distribution

    Nationally