BEUDAMED
    FDA Enforcement Class III Ongoing

    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

    Recall: Z-1461-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1461-2024
    Event ID
    94182
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 10, 2024
    Initiation Date
    February 20, 2024
    Classification Date
    April 2, 2024
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

    Reason

    Product was mislabeled as a Surgical Cap at its dispenser level.

    Code Info

    Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.

    Quantity

    250 cases (75,000 pieces)