BEUDAMED
    FDA Recall Terminated

    Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    Recall: Z-1700-2008 · Initiated April 15, 2008

    Recall

    Recall Number
    Z-1700-2008
    Event Number
    47891
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 15, 2008
    Posted
    September 4, 2008
    Terminated
    September 3, 2008
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    Reason

    Convenience kits may be non-sterile due to inadequate package sealing.

    Action

    Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.

    Distribution

    MO. Foreign distribution to Japan. No military or government distribution.

    Quantity

    10 kits