BEUDAMED
    FDA Enforcement Class II Terminated

    Luer Lock Set - Catalog # MPC-125, for IV administration sets.

    Recall: Z-2354-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2354-2019
    Event ID
    83330
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Molded Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    June 10, 2019
    Classification Date
    August 22, 2019
    Termination Date
    May 28, 2021
    Address
    1112 Chatburn Ave, N/A, Harlan, IA, 51537-2007, United States

    Description

    Luer Lock Set - Catalog # MPC-125, for IV administration sets.

    Reason

    Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

    Code Info

    LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022

    Distribution

    Distribution US nationwide.

    Quantity

    130,000 sets