{
  "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-0653-2021",
      "product_description": "CryoPatch SG Pulmonary Human Cardiac Patch.  The patch 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 patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below  135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.",
      "product_quantity": "2 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: SGP020  Serial Numbers: 11677186, 11679112, and 11681763  UDI: 00877234000485"
    }
  ]
}