Device Recall 0.10 BreathScan Alcohol Detector

  • Model / Serial
    D121898
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    WNCK, Inc, 2408 Timberloch Pl Ste A4, The Woodlands TX 77380-1042
  • Source
    USFDA