BEUDAMED
    FDA Enforcement Class III Terminated

    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    Recall: Z-2325-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2325-2012
    Event ID
    62852
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2012
    Initiation Date
    August 2, 2012
    Classification Date
    September 6, 2012
    Termination Date
    September 4, 2013
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    Reason

    On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.

    Code Info

    Product code KCT; Lot number: 60263

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.

    Quantity

    77 packs