{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77810",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "N/A",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-2788-2017",
      "product_description": "SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA",
      "product_quantity": "733 units",
      "reason_for_recall": "Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter).  The result is a potential sterile barrier breach in the display sets. These display sets are  included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.",
      "recall_initiation_date": "20170629",
      "center_classification_date": "20170729",
      "termination_date": "20210412",
      "report_date": "20170809",
      "code_info": "Lot Numbers:  (a) 1703100033, 1703200057, 1705400037, 1707900050, 1708200042, 1710200084, 1713700057, 1715900028  (b) 1619500015, 1620300020, 1623000025, 1623700026, 1624400017, 1625100125, 1626500068, 1627900033, 1628600023, 1629400030, 1632800035, 1634200023, 1634900050, 1635600025, 1700300019, 1700500032, 1702300048, 1703200053, 1703900069"
    }
  ]
}