BEUDAMED
    FDA Recall Terminated

    Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)

    Recall: Z-0697-2008 · Initiated November 30, 2007

    Recall

    Recall Number
    Z-0697-2008
    Event Number
    45936
    Firm
    Sakar International, Inc.
    FEI Number
    3000203697
    Product Code
    DJZ
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    November 30, 2007
    Posted
    February 5, 2008
    Terminated
    June 30, 2010
    Address
    195 Carter Drive, Edison, NJ, 08817-2068

    Description

    Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)

    Reason

    Marketed without a 510(k)

    Action

    Recall notification letters , Urgent Device Recall, were sent by first class mail on 11/30/2007 requesting return of product and notification of accounts sold product.

    Distribution

    Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.

    Quantity

    72,581