BEUDAMED
    FDA Recall Terminated

    Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.

    Recall: Z-0597-2012 · Initiated October 24, 2011

    Recall

    Recall Number
    Z-0597-2012
    Event Number
    60456
    Firm
    Midmark Corportation
    FEI Number
    1523530
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 24, 2011
    Posted
    January 11, 2012
    Terminated
    June 20, 2014
    Address
    60 Vista Dr, Versailles, OH, 45380

    Description

    Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.

    Reason

    During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.

    Action

    Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275.

    Distribution

    Worldwide Distribution- USA (nationwide) including Puerto Rico and the countries of AUSTRALIA, BELGIUM, BRAZIL, CHILE, CHINA, EGYPT, FRANCE, GUAM, HONG KONG, HUNGARY, ICELAND, INDIA, KOREA, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, POLAND, RUSSIA, SAIPAN MP, SAUDI ARABIA, SEOUL, SINGAPORE, TAIWAN, THAILAND, TURKEY, U.A.E., UNITED KINGDOM and WEST INDIES.

    Quantity

    30,255 units