BEUDAMED
    FDA Recall Terminated

    Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

    Recall: Z-0578-2009 · Initiated September 12, 2008

    Recall

    Recall Number
    Z-0578-2009
    Event Number
    49526
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 12, 2008
    Posted
    January 13, 2009
    Terminated
    January 13, 2009
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

    Reason

    Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.

    Action

    All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.

    Distribution

    United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.

    Quantity

    399 kits