BEUDAMED
    FDA Enforcement Class II Terminated

    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

    Recall: Z-2036-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-2036-2018
    Event ID
    79992
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WRP Asia Pacific Sdn Bhd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 6, 2018
    Initiation Date
    May 7, 2018
    Classification Date
    May 30, 2018
    Termination Date
    May 30, 2019
    Address
    Lot 1, Perusahaan Bandar Baru, Jalan 3, Sepang, N/A, N/A, Malaysia

    Description

    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

    Reason

    Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

    Code Info

    Lot 705366565

    Distribution

    Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX.

    Quantity

    201,000 pairs