BEUDAMED
    FDA Enforcement Class II Ongoing

    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

    Recall: Z-2626-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2626-2023
    Event ID
    92942
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    August 9, 2023
    Classification Date
    September 21, 2023
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

    Reason

    One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

    Code Info

    UDI-DI: 20680651468271; Lot Number AM2164811

    Distribution

    US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia

    Quantity

    41790 masks