BEUDAMED
    FDA Recall 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 · Initiated August 2, 2012

    Recall

    Recall Number
    Z-2325-2012
    Event Number
    62852
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    LRT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 2, 2012
    Posted
    September 6, 2012
    Terminated
    September 4, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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.

    Action

    Steris sent a Urgent Voluntary Recall Notice letter dated August 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Steris has learned that the VIS-U-All tubing is not performing to product specifications. Upon receipt of replacement product we ask that you destroy any remaining inventory of the affected lot in your possession. In the interim period, should you receive a failing result following a sterilization cycle, the results must be handled in accordance with your internal hospital procedures. We apologize for any inconvenience this matter may cause you. For further questions please call 1-(800) 548-4873.

    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