{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "98879",
      "product_res_number": "Z-0158-2015",
      "event_date_initiated": "2011-03-01",
      "event_date_posted": "2014-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-11-06",
      "res_event_number": "58185",
      "product_code": "DTR",
      "k_numbers": [
        "K823451"
      ],
      "product_description": "Terumo  Cardioplegia Delivery Set-             \r\nItem Number: 16130\r\n\r\nProduct Usage:\r\nThe Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.",
      "code_info": "Lot Numbers: MN08, MNI5, MM11, MM18, MM25.  Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.",
      "firm_fei_number": "1000149028",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "28 Howe St",
      "city": "Ashland",
      "state": "MA",
      "postal_code": "01721-1305",
      "additional_info_contact": "Same\n508-231-2400",
      "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",
      "root_cause_description": "Device Design",
      "action": "Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users  users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions:\r\nClamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure.  Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.",
      "product_quantity": "777 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "openfda": {
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        "fei_number": [
          "3044156918",
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          "1721676",
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        ],
        "device_name": "Heat-Exchanger, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4240",
        "device_class": "2"
      }
    }
  ]
}