BEUDAMED
    FDA Recall Terminated

    CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.

    Recall: Z-2197-2008 · Initiated March 14, 2008

    Recall

    Recall Number
    Z-2197-2008
    Event Number
    48658
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 14, 2008
    Posted
    September 11, 2008
    Terminated
    September 9, 2008
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.

    Reason

    Component of convenience kit may not be sterile.

    Action

    The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.

    Distribution

    PA. No military, government, or foreign distribution.

    Quantity

    36 kits