BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2354-2019 · Initiated June 10, 2019

    Recall

    Recall Number
    Z-2354-2019
    Event Number
    83330
    Firm
    Molded Products Inc
    FEI Number
    1000138417
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 10, 2019
    Terminated
    May 28, 2021
    Address
    1112 Chatburn Ave, Harlan, IA, 51537-2007

    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.

    Action

    On June 10, 2019, the firm sent URGENT MEDICAL DEVICE RECALL letters to their consignees advising them of the labeling problem, requesting that they check their stock, notify their end users and complete the attached MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM.

    Distribution

    Distribution US nationwide.

    Quantity

    130,000 sets