BEUDAMED
    FDA Enforcement Class II Terminated

    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

    Recall: Z-3240-2017 · Reported October 11, 2017

    Enforcement

    Recall Number
    Z-3240-2017
    Event ID
    78117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Metrix Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2017
    Initiation Date
    September 13, 2017
    Classification Date
    September 29, 2017
    Termination Date
    May 25, 2018
    Address
    4400 Chavenelle Rd, N/A, Dubuque, IA, 52002-2655, United States

    Description

    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

    Reason

    The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

    Code Info

    UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244,

    Distribution

    AZ, MA, IL, FL

    Quantity

    50 cases of 200 units