BEUDAMED
    FDA Recall Terminated

    Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

    Recall: Z-0746-2010 · Initiated January 29, 2009

    Recall

    Recall Number
    Z-0746-2010
    Event Number
    51104
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    OEZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 29, 2009
    Posted
    January 29, 2010
    Terminated
    June 16, 2011
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

    Reason

    A manufacturing defect may prevent adequate sterilization of the entire device.

    Action

    Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.

    Distribution

    Worldwide Distribution -- United States ( PA and TX) and Japan.

    Quantity

    220 units