BEUDAMED
    FDA Recall Terminated

    Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

    Recall: Z-1731-2010 · Initiated May 5, 2010

    Recall

    Recall Number
    Z-1731-2010
    Event Number
    55661
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 5, 2010
    Posted
    May 28, 2010
    Terminated
    June 1, 2010
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

    Reason

    Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.

    Action

    Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.

    Distribution

    Nationwide Distribution -- GA, IL, MO, NY, PA and WI.

    Quantity

    96 units