{
  "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": "141078",
      "product_res_number": "Z-0345-2016",
      "event_date_initiated": "2015-10-14",
      "event_date_posted": "2015-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-07-01",
      "res_event_number": "72454",
      "product_code": "FMT",
      "k_numbers": [
        "K925006"
      ],
      "product_description": "HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.",
      "code_info": "Lot Numbers:  39098746, 39655101, 39985370, 40067795",
      "firm_fei_number": "1043214",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "city": "Powell",
      "state": "TN",
      "postal_code": "37849-4703",
      "additional_info_contact": "William G. Pittman\n865-362-2901",
      "reason_for_recall": "DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.",
      "root_cause_description": "Process control",
      "action": "DeRoyal issued their recall on 10/14/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals.  The consignees were instructed to destroy and discard the units.   In the case of further distribution, the firm requested that the consignee either notify its customers of the recall or to submit a customer list for DeRoyal to contact them.",
      "product_quantity": "16 cases of 50 units (800 eaches)",
      "distribution_pattern": "Distributed in the states of VA, AL, FL, and CA.",
      "openfda": {
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        ],
        "device_name": "Warmer, Infant Radiant",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5130",
        "device_class": "2"
      }
    }
  ]
}