BEUDAMED
    FDA Recall 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 · Initiated September 18, 2019

    Recall

    Recall Number
    Z-0513-2020
    Event Number
    83890
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 18, 2019
    Terminated
    May 6, 2022
    Address
    Three Lakes Drive, Northfield, IL, 60093

    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.

    Action

    Medline Industries, Inc. notified customers on about 09/18/2019, via "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter. Customers were informed that the heat activated adhesive used to seal the foil pouch was not fully cured during the manufacturing process. As a result, an incomplete seal and premature expiration of the individually packaged Blood Glucose Test Strips has occurred. Inspection using EVENCARE G3 control solution and unused Blood Glucose Test Strips, from the affected lot, has shown that the test strips can produce inaccurate blood glucose readings. Instructions included to immediately check inventory for the affected item and lot number, quarantine affected product, complete and return the enclosed response form, arrange for the return of all affected product, and notify customers if the product was further distributed. Questions can be directed to 866-359-1704.

    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)