{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ashland",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "58185",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "28 Howe St",
      "address_2": "N/A",
      "postal_code": "01721-1305",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "recall_number": "Z-0156-2015",
      "product_description": "Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass  Item Numbers: 5852, 16010    Product Usage:      This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity",
      "product_quantity": "596 units; 876 units",
      "reason_for_recall": "Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line",
      "recall_initiation_date": "20110301",
      "center_classification_date": "20141031",
      "termination_date": "20141106",
      "report_date": "20141112",
      "code_info": "Item Number: 58520-Lot Numbers:  MF24, MM11, MN01.  Manufacturing dates May 24, 20 I 0 through November I, 2010    Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07.  Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0"
    }
  ]
}