BEUDAMED
    FDA Recall 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 · Initiated June 4, 2015

    Recall

    Recall Number
    Z-1826-2015
    Event Number
    71519
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 4, 2015
    Posted
    June 22, 2015
    Terminated
    October 26, 2015
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    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.

    Action

    Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sent directly to their affected accounts. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department. Customers with questions were instructed to contact their Merit Sales Representative or call (801) 208-4365.

    Distribution

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

    Quantity

    1,445