BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0317-2022 · Initiated September 27, 2021

    Recall

    Recall Number
    Z-0317-2022
    Event Number
    88846
    Firm
    O & M HALYARD INC
    FEI Number
    3014421917
    Product Code
    LZC
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    September 27, 2021
    Address
    1 Edison Dr, Alpharetta, GA, 30004-3894

    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.

    Action

    O&M Halyard Inc has issued a voluntary recall of the Sterling Zero Nitrile Powder-free Exam Glove on 10/08/2021 by email or Fed Ex. The letter requested that the consignee segregate and destroy all affected product. Distributors were directed to notify their customers.

    Distribution

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

    Quantity

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