{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "142021",
      "product_res_number": "Z-0416-2016",
      "event_date_initiated": "2015-11-19",
      "event_date_posted": "2015-12-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-02-22",
      "res_event_number": "72718",
      "product_code": "NHC",
      "k_numbers": [
        "K071640"
      ],
      "product_description": "VentriClear II Ventricular Drainage Catheter Set.  Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.",
      "code_info": "Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X",
      "firm_fei_number": "1820334",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "city": "Bloomington",
      "state": "IN",
      "postal_code": "47404-9120",
      "additional_info_contact": "Cook Medical Customer Relations\n812-339-2235",
      "reason_for_recall": "Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.",
      "root_cause_description": "Process control",
      "action": "Cook Medical issued letter via certified mail on 11/19/2015, for their voluntary recall of the VentriClear II Ventricular Drainage Catheter Set due to being sterilized twice.  The Distributor was instructed to forward the recall letter on to its customers, and quarantine any unused recalled devices, and return them to Cook Medical.  Customers with questions may contact: Cook Medical Customer Relations 1-800-457-4500 or 1-812-339-2235. Monday\nthrough Friday between 7:30a.m. and 5:00p.m. Eastern Daylight Time or email at\nCustomerRelationsNA@cookmedical.com.",
      "product_quantity": "35",
      "distribution_pattern": "Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.",
      "openfda": {
        "k_number": [
          "K160223",
          "K011812",
          "K071640"
        ],
        "device_name": "Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4100",
        "device_class": "2",
        "registration_number": [
          "3030447506",
          "3030714660",
          "1820334"
        ],
        "fei_number": [
          "3030447506",
          "3030714660",
          "1820334"
        ]
      }
    }
  ]
}