{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "98620",
      "product_res_number": "Z-0156-2015",
      "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": [
        "K900640"
      ],
      "product_description": "Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass\nItem Numbers: 5852, 16010\n\nProduct Usage:  \n\nThis 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",
      "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",
      "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:\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": "596 units; 876 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "openfda": {
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          "K081838",
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        ],
        "registration_number": [
          "2029275",
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        "fei_number": [
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        ],
        "device_name": "Heat-Exchanger, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4240",
        "device_class": "2"
      }
    }
  ]
}