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U.S. Department of Health and Human Services

Class 2 Device Recall 0.10 BreathScan Alcohol Detector

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  Class 2 Device Recall 0.10 BreathScan Alcohol Detector see related information
Date Initiated by Firm November 30, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on April 25, 2007
Recall Number Z-0323-06
Recall Event ID 34090
Product Classification Devices, Breath Trapping, Alcohol - Product Code DJZ
Product 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.
Code Information D121898
Recalling Firm/
Manufacturer		 WNCK, Inc
2408 Timberloch Pl Ste A4
The Woodlands TX 77380-1042
Manufacturer Reason
for Recall		 Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
FDA Determined
Cause 2		 Other
Action The firm initiated recall on 11/29/05 via letter to all distributor consignees.
Quantity in Commerce 126,552 total units.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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