{
  "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": "50117",
      "product_res_number": "Z-0520-2007",
      "event_date_initiated": "2007-01-24",
      "event_date_posted": "2007-02-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-07-26",
      "res_event_number": "37213",
      "product_code": "KNQ",
      "k_numbers": [
        "K935094"
      ],
      "product_description": "Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105",
      "code_info": "Order number QBD-10X3, Lot number W2287708",
      "firm_fei_number": "1037905",
      "recalling_firm": "Cook Endoscopy",
      "address_1": "5951 Grassy Creek Blvd",
      "city": "Winston Salem",
      "state": "NC",
      "postal_code": "27105-1206",
      "additional_info_contact": "Sharon Miles\n336-767-2657 Ext. 6325",
      "reason_for_recall": "The graphic label is incorrect, it lists 6mm/ 18FR.  The product label is correct, it lists 10mm/ 30FR.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.",
      "product_quantity": "12 units",
      "distribution_pattern": "Worldwide, including NY and TX in USA, Australia, Canada and India.",
      "openfda": {
        "k_number": [
          "K093236",
          "K830586",
          "K934697",
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          "K884715",
          "K090183",
          "K983373",
          "K853274",
          "K974788",
          "K061937",
          "K061787",
          "K993720",
          "K862000",
          "K002363",
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          "K082995",
          "K830991",
          "K933992",
          "K031147",
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        ],
        "device_name": "Dilator, Esophageal",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5365",
        "device_class": "2"
      }
    }
  ]
}