{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43098",
      "product_res_number": "Z-0323-06",
      "event_date_initiated": "2005-11-30",
      "event_date_posted": "2005-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-04-25",
      "res_event_number": "34090",
      "product_code": "DJZ",
      "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.",
      "code_info": "D121898",
      "firm_fei_number": "3004057121",
      "recalling_firm": "WNCK, Inc",
      "address_1": "2408 Timberloch Pl Ste A4",
      "city": "The Woodlands",
      "state": "TX",
      "postal_code": "77380-1042",
      "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.",
      "root_cause_description": "Other",
      "action": "The firm initiated recall on 11/29/05 via letter to all distributor consignees.",
      "product_quantity": "126,552 total units.",
      "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.",
      "openfda": {
        "k_number": [
          "K102338",
          "K071067",
          "K041334",
          "K052448",
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          "K062545",
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          "K043188",
          "K053332",
          "K063443",
          "K091714",
          "K160613",
          "K060761",
          "K072953",
          "K090766",
          "K081855",
          "K082086",
          "K080848",
          "K093143",
          "K110614",
          "K082080",
          "K083801",
          "K061922",
          "K060343"
        ],
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        "fei_number": [
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          "3002653540",
          "3011119387",
          "3001451797",
          "1000352675",
          "1832216",
          "3000210620"
        ],
        "device_name": "Devices, Breath Trapping, Alcohol",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3050",
        "device_class": "1"
      }
    }
  ]
}