BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1320-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1320-2014
    Event ID
    67844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    March 13, 2014
    Classification Date
    April 3, 2014
    Termination Date
    July 7, 2014
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    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.

    Code Info

    Lot Number H574228

    Distribution

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

    Quantity

    15