BEUDAMED
    FDA Enforcement Class II Terminated

    3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.

    Recall: Z-2002-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2002-2014
    Event ID
    68415
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 9, 2014
    Classification Date
    July 7, 2014
    Termination Date
    June 3, 2015
    Address
    3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, 55144, United States

    Description

    3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.

    Reason

    Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.

    Code Info

    All serial numbers.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.

    Quantity

    5343 (2621 USA, 2722 OUS)