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.
This recall has been terminated (originally issued December 23, 2005).
- Company
- Wnck, Inc
- Recall Initiated
- November 30, 2005
- Posted
- December 23, 2005
- Terminated
- April 25, 2007
- Recall Number
- Z-0323-06
- Quantity
- 126,552 total units.
- Firm Location
- The Woodlands, TX
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
D121898
Root Cause
Other
Action Taken
The firm initiated recall on 11/29/05 via letter to all distributor consignees.