{
  "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-1310-2019",
      "product_description": "MoniTorr\t10100\t10-100\tCSF Drainage System w/Patient Line One Way Valve  MoniTorr\t10102\t10-102\tCSF Drainage System w/Patient Line One Way Valve w  MoniTorr\t10110\t10-110\tCSF Drainage System used with Pole Mount System  MoniTorr\t10140\t10-140\tCSF Drainage System w/Vinyl Measuring Strip  MoniTorr\t10150\t10-150\tCSF Drainage System Simple Bag and Line  MoniTorr\t10110A\t10-110A\tCSF Drainage System w/o Manifold Stopcock  MoniTorr\tSP0017\tSP0017\tSpecial EVD 10-110 w/o Y Site Latex Free Sites  MoniTorr\tSP0042\tSP0042\tSpecial EVD 10-100 w/o Y Site  MoniTorr\tSP0090\tSP0090\tSpecial EVD 10-110 w/o Y Site  MoniTorr\tSP0164\tSP0164\tSpecial EVD 10-140 w/Y Site & Stopcock Reverse  MoniTorr\tSP0236\tSP0236\tINS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI     Product Usage:  The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion.  Indications: The MoniTorr ICP 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 inpatients 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"
    }
  ]
}