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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.

FDA Recall Z-0323-06 · Posted 2005-12-23

Recalling FirmWNCK, Inc
Recall StatusTerminated
Product CodeDJZ
Date Initiated2005-11-30
Date Terminated2007-04-25
Product Quantity126,552 total units.

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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