{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35424",
      "product_res_number": "Z-0169-05",
      "event_date_initiated": "2004-05-06",
      "event_date_posted": "2004-11-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-06-29",
      "res_event_number": "30218",
      "product_code": "MIE",
      "product_description": "CryoValve, Pulmonary Valve and Conduit - SG",
      "code_info": "Donor #55634, Serial #7250375, Model #SGPV00* Donor #60740, Serial #7756769, Model #SGPV00*  Donor #60758, Serial #7765469, Model #SGPV00*  Donor #60760, Serial #7753955, Model #SGPV00*  Donor #63969, Serial #7907208, Model #SGPV00*  Donor #64863, Serial #7865589, Model #SGPV00",
      "firm_fei_number": "3001451326",
      "recalling_firm": "Cryolife Inc",
      "address_1": "1655 Roberts Blvd Nw",
      "city": "Kennesaw",
      "state": "GA",
      "postal_code": "30144-3632",
      "additional_info_contact": "Mr. P. Tyler Cochran, CQA, CTBS\n770-419-3355",
      "reason_for_recall": "CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter on/about May 6, 2004.",
      "product_quantity": "6 units",
      "distribution_pattern": "Nationwide, Austria, Canada, Germany",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}