{
  "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": "98878",
      "product_res_number": "Z-0157-2015",
      "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": "KRI",
      "k_numbers": [
        "K810079"
      ],
      "product_description": "Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852    \r\nItem Number: 16110\r\n\r\nProduct Usage:  This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity",
      "code_info": "Lot Numbers: ML13, MM04.  Manufacturing datese September 13, 2010 through October 4, 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": "165 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
      "openfda": {
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          "K792151",
          "K864890",
          "K811348",
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          "K822097",
          "K892856",
          "K862510",
          "K851289",
          "K790192",
          "K841812"
        ],
        "registration_number": [
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          "1646747",
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          "3010402691",
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          "3004605321",
          "1000112968",
          "3004053982",
          "3002808327",
          "3005426550",
          "3006849754"
        ],
        "device_name": "Accessory Equipment, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4200",
        "device_class": "1"
      }
    }
  ]
}