{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Kennesaw",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86890",
      "recalling_firm": "CryoLife, Inc.",
      "address_1": "1655 Roberts Blvd Nw",
      "address_2": "N/A",
      "postal_code": "30144-3632",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Distributed nationwide to GA, AZ, TX, MO, and OK.",
      "recall_number": "Z-0652-2021",
      "product_description": "CryoValve SG Pulmonary Human Heart Valve.  The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below  135¿C.  CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.",
      "product_quantity": "3 units",
      "reason_for_recall": "On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.",
      "recall_initiation_date": "20201110",
      "center_classification_date": "20201221",
      "termination_date": "20211026",
      "report_date": "20201230",
      "code_info": "Model/Catalog Number: SGPV00  Serial Numbers: 11685214, 11685554, and 11682491  UDI: 00877234000447"
    }
  ]
}