BEUDAMED
    FDA Enforcement Class II Terminated

    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

    Recall: Z-2742-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2742-2018
    Event ID
    80650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    February 2, 2018
    Classification Date
    August 10, 2018
    Termination Date
    November 30, 2020
    Address
    1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States

    Description

    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

    Reason

    Supplier manufacturing defect with the syringe plunger tip.

    Code Info

    Catalog Number: Lot Number: K01-05526P H1258821, K01-07427 H1263015, K01-07477P H1250809 and H1242962, K01-07930P H1246733, MSS011-DG H1246809, K02-00565C H1258361, MSS011-LG H1246810, K02-01260B H1258575 and H1265248, MSS011-PR H1242752, MSS011-R H1242754 and H1255507, K02-01331A H1252652, K04-00748 H1258488 and H1264381, MSS011-Y H1246811, MSS011-YP H1242927, K12-03636 H1258530, and MSS011 H1242750, H1246807 and H1255504.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.

    Quantity

    22,234