BEUDAMED
    FDA Enforcement Class II Terminated

    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039

    Recall: Z-0793-2021 · Reported January 13, 2021

    Enforcement

    Recall Number
    Z-0793-2021
    Event ID
    86942
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2021
    Initiation Date
    December 2, 2020
    Classification Date
    January 7, 2021
    Termination Date
    June 21, 2022
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039

    Reason

    Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch

    Code Info

    Lot Number: 200428A, 200628A

    Distribution

    Nationwide Foreign:

    Quantity

    170 cases