{
  "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": "48573",
      "product_res_number": "Z-0315-2007",
      "event_date_initiated": "2004-05-01",
      "event_date_posted": "2006-12-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-07-14",
      "res_event_number": "36395",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).",
      "code_info": "Serial numbers 0040 through 0044.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.",
      "root_cause_description": "Process control",
      "action": "U.S. consignees were visited and corrections made between May 2004 and November 2005.  Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.",
      "product_quantity": "5",
      "distribution_pattern": "Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.",
      "openfda": {
        "k_number": [
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        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
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}