{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "98953",
      "product_res_number": "Z-0159-2015",
      "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": "OEZ",
      "product_description": "Terumo Custom Cardiovascular and Perfusion Procedure Kits\nCatalog Codes: Kits with a 5-digit code beginning with the digit  6: \nCatalog Number: 6XXXX ;\nCatalog Codes: Kits with a 5-digit code beginning with the digit  7: Catalog Number: 7XXXX \n\nProduct usage:\nThe Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.",
      "code_info": "Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22.  Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0.  Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.",
      "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": "Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and the countries of  Canada, Brazil, Hong Kong, Korea, and Thailand.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
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}