{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "31614",
      "product_res_number": "Z-0738-04",
      "event_date_initiated": "2002-04-30",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-03-24",
      "res_event_number": "28335",
      "product_code": "DTJ",
      "k_numbers": [
        "K960169"
      ],
      "product_description": "Carbomedics VT-200 Valve Tester",
      "code_info": "All lots",
      "firm_fei_number": "1627803",
      "recalling_firm": "Carbomedics, Inc",
      "address_1": "1300 E Anderson Ln",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78752-1708",
      "reason_for_recall": "Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.",
      "root_cause_description": "Other",
      "action": "Letters were sent to surgeons and hospital operating room supervisors in mid-May 2002 which included the following information:\nIt is imperative that hospitals regularly and thoroughly inspect all testing instruments for indications of wear and degredation.  And, CarboMedics is in the process of re-issuing suggested maintenance and sterilization guidlines.",
      "product_quantity": "4606 units",
      "distribution_pattern": "US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal, Ecuador, India, Japan, Hong Kong, Italy, Sweden, Belgium, Norway, Argentina, Spain, Malta, Austria, Switzerland, Netherlands, Germany, Australia, Finland",
      "openfda": {
        "k_number": [
          "K944214",
          "K960169",
          "K942736",
          "K811236",
          "K792034",
          "K864155",
          "K871596",
          "K811235",
          "K790022",
          "K962154",
          "K813276",
          "K880052"
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          "2015691",
          "2135147",
          "2134285",
          "3010701807",
          "3008592544",
          "1063481",
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          "1649833",
          "3008500478",
          "3007113487",
          "2133928",
          "3005687633",
          "1721676"
        ],
        "fei_number": [
          "2015691",
          "3010701807",
          "3008592544",
          "3001451326",
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          "3000717902",
          "3007113487",
          "3005334138",
          "1713910",
          "3005687633",
          "1721676",
          "3001584317"
        ],
        "device_name": "Holder, Heart-Valve, Prosthesis",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3935",
        "device_class": "1"
      }
    }
  ]
}