{
  "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": "30303",
      "product_res_number": "Z-0167-04",
      "event_date_initiated": "2003-11-04",
      "event_date_posted": "2003-11-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-05-06",
      "res_event_number": "27664",
      "product_code": "MIE",
      "product_description": "CryoValve Pulmonary Valve & Conduct",
      "code_info": "Model Number PV00, Serial Number 8041312",
      "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": "Sylvie L. Verdon\n770-419-3355",
      "reason_for_recall": "CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture.  Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.",
      "root_cause_description": "Other",
      "action": "Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.",
      "product_quantity": "One unit",
      "distribution_pattern": "The tissue was shipped to one hospital in MO.",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}