BEUDAMED
    FDA Enforcement Class II Ongoing

    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500

    Recall: Z-0729-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0729-2025
    Event ID
    95804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2025
    Initiation Date
    November 8, 2024
    Classification Date
    December 20, 2024
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500

    Reason

    Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

    Code Info

    UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28

    Distribution

    Nationwide

    Quantity

    637 cases