Recall Z-0323-06 ยท DJZ Devices, Breath Trapping, Alcohol
WNCK, Inc
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
| Date | Dec 23, 2005 (initiated Nov 30, 2005) |
| Status | Terminated |
| Reason | Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff. |
| Root cause | Other |
| Action | The firm initiated recall on 11/29/05 via letter to all distributor consignees. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.