BEUDAMED
    FDA Enforcement Class III Ongoing

    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

    Recall: Z-1059-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1059-2023
    Event ID
    91530
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Owens & Minor Distribution, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 15, 2023
    Initiation Date
    January 3, 2023
    Classification Date
    February 3, 2023
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

    Reason

    Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

    Code Info

    UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

    Distribution

    US distribution to IL, NC, NY, OH, and PA.

    Quantity

    73 cases