BEUDAMED
    FDA Recall 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 · Initiated March 23, 2017

    Recall

    Recall Number
    Z-1889-2017
    Event Number
    76938
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 23, 2017
    Terminated
    September 26, 2017
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    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.

    Action

    Consignees began receiving notification via letter on March 23, 2017 to immediately stop using or distributing the affected lots and return them back to Merit. If there are any questions, contact Merit Customer Service at (801) 208-4381.

    Distribution

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

    Quantity

    23,032 units