BEUDAMED
    FDA Recall Terminated

    Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.

    Recall: Z-0519-2010 · Initiated September 29, 2009

    Recall

    Recall Number
    Z-0519-2010
    Event Number
    53557
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2009
    Posted
    December 14, 2009
    Terminated
    December 15, 2009
    Address
    1600 Merit Pkwy South, Jordan, UT, 84095

    Description

    Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.

    Reason

    Potential sterility breach caused by excessive shipment damage.

    Action

    Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.

    Distribution

    US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.

    Quantity

    5 Sheath Introducers