{
  "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": "30787",
      "product_res_number": "Z-0516-04",
      "event_date_initiated": "2003-11-10",
      "event_date_posted": "2004-02-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-05-06",
      "res_event_number": "27949",
      "product_code": "MIE",
      "product_description": "CryoValve, Pulmonary Valve & Conduit",
      "code_info": "Donor number: 71237, Serial number: 8214013, Model number: 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": "P. Tyler Cochran, CQA, CTBS\n770-419-3355",
      "reason_for_recall": "The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.",
      "root_cause_description": "Other",
      "action": "Consignee was first  notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.",
      "product_quantity": "1 unit",
      "distribution_pattern": "The tissue was issued to one hospital in CA.",
      "openfda": {
        "device_name": "Heart-Valve, Allograft",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}