BEUDAMED
    FDA Enforcement Class II Terminated

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

    Recall: Z-1119-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1119-2022
    Event ID
    90050
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 1, 2022
    Initiation Date
    March 22, 2022
    Classification Date
    May 20, 2022
    Termination Date
    January 29, 2024
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

    Reason

    Product not approved for release for US distribution

    Code Info

    Lot Number: 202108

    Distribution

    Nationwide

    Quantity

    152 cases