{
  "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": "49817",
      "product_res_number": "Z-0378-2007",
      "event_date_initiated": "2006-12-15",
      "event_date_posted": "2007-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-04",
      "res_event_number": "37051",
      "product_code": "KAC",
      "product_description": "Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.",
      "code_info": "Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.",
      "firm_fei_number": "1824231",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "5700 W 23rd Ave",
      "city": "Gary",
      "state": "IN",
      "postal_code": "46406-2617",
      "additional_info_contact": "Pat Oxyer\n800-858-7670 Ext. 5566",
      "reason_for_recall": "The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.",
      "root_cause_description": "Other",
      "action": "Consignees were notified via recall letter dated 12/15/06.  Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall.  The firm is  advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.",
      "product_quantity": "117",
      "distribution_pattern": "Worldwide, including USA, Canada,  Netherlands and United Kingdom.",
      "openfda": {
        "device_name": "Tube, Laryngectomy",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.4420",
        "device_class": "1",
        "registration_number": [
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        "k_number": [
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}