Events

Recall of Device Recall 0.10 BreathScan Alcohol Detector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by WNCK, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34090
  • Event Risk Class
    Class 2
  • Event Number
    Z-0323-06
  • Event Initiated Date
    2005-11-30
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43098
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Devices, Breath Trapping, Alcohol - Product Code DJZ
  • Reason
    Device marketed without 510(k) as required; 0.10% breathscan alcohol detector turning positive with breath alcohol samples 50% below the test cutoff.
  • Action
    The firm initiated recall on 11/29/05 via letter to all distributor consignees.

Device

Device Recall 0.10 BreathScan Alcohol Detector
  • Model / Serial
    D121898
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    WNCK, Inc

Manufacturer

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