{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82659",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "address_2": "N/A",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide   International distribution to Argentina, American Samoa, Australia, Canada, and Guam.",
      "recall_number": "Z-1312-2019",
      "product_description": "LimiTorr\tINS9020\tINS-9020\tLIMITORR VOLUME LIMITING EVD 20 ML  LimiTorr\tINS9020SP1\tINS-9020SP1\tLIMITORR VOLUME EVD 20ML  LimiTorr\tINS9030\tINS-9030\tLIMITORR VOLUME LIMITING EVD 30 ML  LimiTorr\tINS9030SP1\tINS-9030SP1\tLIMITORR VOLUME LIMITING EVD 30 ML    Product Usage:  The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve  mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached.  Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.",
      "product_quantity": "42102 units",
      "reason_for_recall": "The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.",
      "recall_initiation_date": "20190408",
      "center_classification_date": "20190520",
      "termination_date": "20210127",
      "report_date": "20190529",
      "code_info": "All lots"
    }
  ]
}