BEUDAMED
    FDA Enforcement Class II Terminated

    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

    Recall: Z-1826-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1826-2015
    Event ID
    71519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    June 4, 2015
    Classification Date
    June 22, 2015
    Termination Date
    October 26, 2015
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095, United States

    Description

    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

    Reason

    Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

    Code Info

    Catalo Number PR0-6F-11-038, Lot Number H767887

    Distribution

    Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.

    Quantity

    1,445