{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197233",
      "product_res_number": "Z-0735-2023",
      "event_date_initiated": "2022-11-18",
      "event_date_posted": "2022-12-20",
      "recall_status": "Open, Classified",
      "res_event_number": "91193",
      "product_code": "PSP",
      "product_description": "The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).",
      "code_info": "Part Number: HITH1\nUDI-DI Code: 382830048590\nLot Number: 22GDB675\n\nPart Number: HITHNDRZR\nUDI-DI Code: 382830048620\nLot Number: 22HDA557\n\nPart Number: HITHLT\nUDI-DI Code: 382830048637\nLot Number: 22IDB724",
      "firm_fei_number": "2023988",
      "recalling_firm": "Natus Medical Incorporated",
      "address_1": "5955 Pacific Center Blvd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4309",
      "additional_info_contact": "Technical Service Team\n858-455-1115",
      "reason_for_recall": "Due to Cranial Access Kits containing recalled sterile surgical drapes.  The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 11/18/2022, the firm sent an \"Amended Urgent Field Safety Notice - Recall\" letter via first class mail to customers informing them that the 3M surgical drapes that are included in Natus Cranial Access Kits are being recalled by 3M Healthcare due to the liner on the adhesive component of the affected drapes are difficult to remove without damaging the product and may render the product unusable.  In addition there is the potential for adhesive related skin injures.\n\nCustomers are instructed to:\n1. Complete the enclosed form, and return to FCA@Natus.com\n2. Immediately cease use of the affected Cranial Access Kits that you have and quarantine until you receive the shipping instructions from Natus to return the product(s). Customers will receive shipping instructions from FCA@Natus.com\n\nFor questions or further assistance contact Natus Technical Service Team via email FCA@natus.com",
      "product_quantity": "249 kits",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.",
      "openfda": {
        "registration_number": [
          "1423537",
          "9616088",
          "1061124",
          "3042989733",
          "3009888344",
          "3002821232",
          "1422634",
          "1643817",
          "3007329020",
          "2023988",
          "3004111573"
        ],
        "fei_number": [
          "1000514656",
          "1000512168",
          "3042989733",
          "3001236905",
          "3002902735",
          "3009888344",
          "3002821232",
          "1643817",
          "3007329020",
          "2023988",
          "3004111573"
        ],
        "device_name": "Intracranial Pressure & Temperature Monitoring Kit",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1620",
        "device_class": "2"
      }
    }
  ]
}