BEUDAMED
    FDA Recall Terminated

    Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.

    Recall: Z-0847-2007 · Initiated April 17, 2007

    Recall

    Recall Number
    Z-0847-2007
    Event Number
    37902
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2007
    Posted
    May 31, 2007
    Terminated
    May 5, 2008
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.

    Reason

    Male luer in fluid administration sets may crack due to inadequate molding process

    Action

    Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.

    Distribution

    CA, IL, NJ, NY. No military, government or foreign distribution.

    Quantity

    17 units