{
  "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": "26246",
      "product_res_number": "Z-0672-03",
      "event_date_initiated": "2003-02-04",
      "event_date_posted": "2003-03-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-07-16",
      "res_event_number": "25675",
      "product_code": "MIE",
      "product_description": "CryoValve Allograft, Heart valve",
      "code_info": "Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.",
      "firm_fei_number": "3001451326",
      "recalling_firm": "Cryolife Inc",
      "address_1": "1655 Roberts Blvd Nw",
      "city": "Kennesaw",
      "state": "GA",
      "postal_code": "30144",
      "additional_info_contact": "Shari Allen\n770-419-3355",
      "reason_for_recall": "Microorganisms were detected in distributed allografts.",
      "root_cause_description": "Other",
      "action": "CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department  Field Assurance, who will issue a Return Materials Authorization (RMA) number and will  provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. \n\nHealth Canada was notified of all voluntary actions on the allografts distributed in Canada.",
      "product_quantity": "2 units",
      "distribution_pattern": "The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}