BEUDAMED
    FDA Recall Terminated

    0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

    Recall: Z-0323-06 · Initiated November 30, 2005

    Recall

    Recall Number
    Z-0323-06
    Event Number
    34090
    Firm
    WNCK, Inc
    FEI Number
    3004057121
    Product Code
    DJZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 30, 2005
    Posted
    December 23, 2005
    Terminated
    April 25, 2007
    Address
    2408 Timberloch Pl, Ste A4, The Woodlands, TX, 77380-1042

    Description

    0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

    Reason

    Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.

    Action

    The firm initiated recall on 11/29/05 via letter to all distributor consignees.

    Distribution

    Nationwide; product distributed to distributors, retailers and consumers/users in CA, CO, FL, LA, MN, MS, NY, OH, PA, TN, TX, VA, WA. Product also distributed to Markham, Ontario, Canada and Kfar Saba, Israel.

    Quantity

    126,552 total units.