BEUDAMED
    FDA Enforcement Class II Terminated

    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

    Recall: Z-1544-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1544-2020
    Event ID
    85022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    February 10, 2020
    Classification Date
    March 20, 2020
    Termination Date
    February 13, 2023
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

    Reason

    Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

    Code Info

    REF DYND70288 2/PK Expiration 06/30/2022

    Distribution

    US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

    Quantity

    1,541,532 units