{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "103872",
      "product_res_number": "Z-0016-2012",
      "event_date_initiated": "2011-08-23",
      "event_date_posted": "2011-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-01-30",
      "res_event_number": "59854",
      "product_code": "OFD",
      "product_description": "DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer:  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849, USA: \n\n\nIntended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.",
      "code_info": "Lot Numbers:  25402698, 25834829",
      "firm_fei_number": "3005011024",
      "recalling_firm": "Deroyal Industries, Inc. Lafollette",
      "address_1": "1501 East Central Ave",
      "city": "La Follette",
      "state": "TN",
      "postal_code": "37766-2892",
      "additional_info_contact": "Mr. Tracy Edmundson\n865-362-2334",
      "reason_for_recall": "The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, DeRoyal, sent a \"URGENT: MEDICAL DEVICE RECALL\" letter dated September 13, 2011 to its customers.  The letter describes product, problem, and actions to be taken.  Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use.  Constomers were asked to return affected product they have in inventory.  DeRoyal will replace this product free of charge.  Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory.  DeRoyal will replace this product free of charge.    \n Distributors were instructed to perform a sub-recall to their customers.\n\nCustomers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.",
      "product_quantity": "200 units",
      "distribution_pattern": "Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.",
      "openfda": {
        "registration_number": [
          "3045816907",
          "1423395",
          "1526863",
          "1422634",
          "3004519921",
          "3015173212",
          "3008500478",
          "3008998256",
          "3005012805",
          "3035642068",
          "3005595283",
          "3045816902",
          "1928237",
          "3009746061",
          "1030451",
          "1061124"
        ],
        "fei_number": [
          "3045816907",
          "1000514656",
          "1526863",
          "3005846326",
          "1000512168",
          "1713910",
          "3008998256",
          "3005012805",
          "3035642068",
          "3000717925",
          "3005595283",
          "3045816902",
          "1928237",
          "3009746061",
          "1030451",
          "3015173212"
        ],
        "device_name": "Catheter Introducer Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1340",
        "device_class": "2"
      }
    }
  ]
}