{
  "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": "29794",
      "product_res_number": "Z-0065-04",
      "event_date_initiated": "2003-09-25",
      "event_date_posted": "2003-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-05-06",
      "res_event_number": "27390",
      "product_code": "MIE",
      "product_description": "CryoValve, Pulmonary Heart Valve",
      "code_info": "Donor #68830, Serial #8038836, Model #PV10",
      "firm_fei_number": "3001451326",
      "recalling_firm": "Cryolife Inc",
      "address_1": "1655 Roberts Blvd Nw",
      "city": "Kennesaw",
      "state": "GA",
      "postal_code": "30144",
      "additional_info_contact": "Sylvie L. Verdon\n770-419-3355",
      "reason_for_recall": "Additional information  obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.",
      "root_cause_description": "Other",
      "action": "The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification.",
      "product_quantity": "1 unit",
      "distribution_pattern": "The tissue was distributed to one physician in CA.",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}