BEUDAMED
    FDA Recall Terminated

    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

    Recall: Z-1320-2014 · Initiated March 13, 2014

    Recall

    Recall Number
    Z-1320-2014
    Event Number
    67844
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    March 13, 2014
    Posted
    April 3, 2014
    Terminated
    July 7, 2014
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

    Reason

    The products are labeled as sterile but were not sterilized.

    Action

    Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.

    Distribution

    Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.

    Quantity

    15