{
  "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": "130532",
      "product_res_number": "Z-0106-2015",
      "event_date_initiated": "2014-10-08",
      "event_date_posted": "2014-10-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-04-08",
      "res_event_number": "69436",
      "product_code": "GZL",
      "k_numbers": [
        "K944061"
      ],
      "product_description": "Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX .\nPouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.\n\nBox Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX .\nPouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.",
      "code_info": "Lot number 208140447  Batch Number 0060002;  Lot Number 208140458  Batch Number 0061723; LotNumber208140487R Batch Number 0067938.",
      "firm_fei_number": "2183456",
      "recalling_firm": "Ad-Tech Medical Instrument Corporation",
      "address_1": "1901 William St",
      "city": "Racine",
      "state": "WI",
      "postal_code": "53404-1876",
      "additional_info_contact": "Customer Support\n262-634-1555",
      "reason_for_recall": "The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .",
      "root_cause_description": "Process control",
      "action": "Consignees were sent  on 10/8/2014 an AD-TECH \"Medical Device Recall\" letter dated October 6, 2014.  The letter described the Reason for the Voluntary Recall, Risk to Health, Action to be taken by the Customer, Product and Distribution Information and Other Information. Requested consignees to return the \"Acknowledgement and Receipt Form\" to their Ad-Tech Clinical Specialists Fax 262-634-5668, Telephone 262-634-1555, customersupport@adtechmedical.com. For additional information they can use the same number.",
      "product_quantity": "13 kits (26 electrodes, 26 applicator wands, 26 leadwires).",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.",
      "openfda": {
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        "device_name": "Electrode, Depth",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1330",
        "device_class": "2"
      }
    }
  ]
}