BEUDAMED
    FDA Enforcement Class II Terminated

    1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.

    Recall: Z-1889-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1889-2017
    Event ID
    76938
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2017
    Initiation Date
    March 23, 2017
    Classification Date
    April 27, 2017
    Termination Date
    September 26, 2017
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.

    Reason

    Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.

    Code Info

    Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.

    Distribution

    Nationwide and other foreign consignees. No VA/govt/military or VA consignees.

    Quantity

    23,032 units