{
  "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": "120017",
      "product_res_number": "Z-0057-2014",
      "event_date_initiated": "2013-06-11",
      "event_date_posted": "2013-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-02-18",
      "res_event_number": "65742",
      "product_code": "GWM",
      "k_numbers": [
        "K040235"
      ],
      "product_description": "Inegra Licox Brain Tissue Oxygen Monitoring\n1 x Complete Brain Tunneling Probe Kit \nREF IT2\n\n Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany \nDistributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA\n\nUsed in direct monitoring of the partial pressure of oxygen.",
      "code_info": "K040244  Lot #190712; 240512;280612",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "Mr. Srinivas Balusu\n609-936-2464",
      "reason_for_recall": "Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.",
      "product_quantity": "109 kits",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.",
      "openfda": {
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        "device_name": "Device, Monitoring, Intracranial Pressure",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1620",
        "device_class": "2"
      }
    }
  ]
}