BEUDAMED
    FDA Enforcement Class II Ongoing

    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

    Recall: Z-0317-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0317-2022
    Event ID
    88846
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    O&M HALYARD INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 8, 2021
    Initiation Date
    September 27, 2021
    Classification Date
    December 1, 2021
    Address
    1 Edison Dr, Alpharetta, GA, 30004-3894, United States

    Description

    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

    Reason

    All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

    Code Info

    All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630

    Distribution

    Worldwide distribution - US Nationwide and the countries of EU/Canada.

    Quantity

    2,928 cases (5,856,000 gloves)