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 Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    Recall: Z-0761-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0761-2018
    Event ID
    79100
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    June 15, 2017
    Classification Date
    February 27, 2018
    Termination Date
    July 17, 2018
    Address
    5960 Heisley Rd, N/A, 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 Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    Reason

    On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate 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

    Model# 884039 Lot# 161228A and #170228A

    Distribution

    US Nationwide Distribution

    Quantity

    139