{
  "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": "45401",
      "product_res_number": "Z-0836-06",
      "event_date_initiated": "2006-04-06",
      "event_date_posted": "2006-05-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-08-12",
      "res_event_number": "35140",
      "product_code": "KGC",
      "k_numbers": [
        "K910492"
      ],
      "product_description": "18F Tri-Funnel Replacement Gastrostomy Tube",
      "code_info": "Product Code 000718.  Lot numbers: NGPL1892, NGPL2765.",
      "firm_fei_number": "3006260740",
      "recalling_firm": "Bard Access Systems, Inc",
      "address_1": "5425 Amelia Earhart Dr",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84116-3713",
      "additional_info_contact": "801-595-0700",
      "reason_for_recall": "Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If  an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.",
      "root_cause_description": "Error in labeling",
      "action": "Consignees were notified by letter on 04/06/2006.",
      "product_quantity": "114 units",
      "distribution_pattern": "Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia",
      "openfda": {
        "k_number": [
          "K120587",
          "K901791",
          "K191844",
          "K902121",
          "K900884",
          "K903036",
          "K193612",
          "K781333",
          "K904801",
          "K903086",
          "K183057",
          "K223916",
          "K860441",
          "K901795",
          "K980145",
          "K894653",
          "K170323",
          "K910584",
          "K242211",
          "K910492",
          "K080253",
          "K904779",
          "K182832",
          "K073718",
          "K093312",
          "K901501"
        ],
        "device_name": "Tube, Gastro-Enterostomy",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2",
        "registration_number": [
          "3008717566",
          "3015259858",
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          "3005099803",
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        "fei_number": [
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}