BEUDAMED
    FDA Enforcement Class II Completed

    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

    Recall: Z-0902-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0902-2022
    Event ID
    89832
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 15, 2022
    Classification Date
    April 8, 2022
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

    Reason

    Product was distributed without being sterilized.

    Code Info

    Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939

    Distribution

    Product distributed throughout United States and Guam

    Quantity

    486,578 pairs