BEUDAMED
    FDA Enforcement Class II Terminated

    EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.

    Recall: Z-0513-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0513-2020
    Event ID
    83890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    September 18, 2019
    Classification Date
    November 22, 2019
    Termination Date
    May 6, 2022
    Address
    Three Lakes Drive, Northfield, IL, 60093, United States

    Description

    EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.

    Reason

    Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

    Code Info

    Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020

    Distribution

    Nationwide distribution to CA, CT, GA, ID, IL, IN, KS, MA, MI, MN, MO, MS, NV, OH, OR, SC, TN, TX, UT, WA, WI, WY.

    Quantity

    761 boxes (38,050 foil pouches)