{
  "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": "35516",
      "product_res_number": "Z-0477-06",
      "event_date_initiated": "2004-05-06",
      "event_date_posted": "2006-02-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-06-28",
      "res_event_number": "30233",
      "product_code": "MIE",
      "product_description": "CryoValve, Pulmonary Valve & Conduit",
      "code_info": "Donor #40658, Serial #6547591, Model #PV00* Donor #40914, Serial #6565514, Model #PV00*\t Donor #52097, Serial #7082478, Model #PV00*\t Donor #52100, Serial #7085341, Model #PV00*\t Donor #52647, Serial #7075544, Model #PV00*\t Donor #54259, Serial #7284361, Model #PV00",
      "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": "During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter dated May 6, May 11, or May 12, 2004.",
      "product_quantity": "6 units",
      "distribution_pattern": "FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}