BEUDAMED
    FDA Enforcement Class II Terminated

    Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

    Recall: Z-0865-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0865-2020
    Event ID
    84665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    January 7, 2020
    Classification Date
    January 24, 2020
    Termination Date
    September 16, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

    Reason

    There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

    Code Info

    Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

    Distribution

    Kentucky. No governmental, Canadian, or Mexican consignees.

    Quantity

    500