{
  "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": "64440",
      "product_res_number": "Z-0206-2009",
      "event_date_initiated": "2008-07-18",
      "event_date_posted": "2008-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-07-07",
      "res_event_number": "44852",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 base; Model 801764.  NOTE:  This device is not sold in the United States.\n\nFor use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.",
      "code_info": "Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "Local pump controls including start/stop button, select button and manual button may not function.",
      "root_cause_description": "Component design/selection",
      "action": "Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.",
      "product_quantity": "300",
      "distribution_pattern": "Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",
      "openfda": {
        "k_number": [
          "K080832",
          "K813034",
          "K202125",
          "K221373",
          "K942582",
          "K002116",
          "K103762",
          "K030141",
          "K915183",
          "K060053",
          "K964017",
          "K011088",
          "K052555",
          "K002118",
          "K153376",
          "K210130",
          "K851614",
          "K090006",
          "K172220",
          "K020571",
          "K842138",
          "K070213",
          "K943803",
          "K851615",
          "K861388",
          "K772001",
          "K131041",
          "K982014",
          "K871131",
          "K022947",
          "K021694",
          "K133598",
          "K863960",
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          "K801097",
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          "K870976",
          "K093882",
          "K190282",
          "K163531",
          "K091007",
          "K071318"
        ],
        "registration_number": [
          "3019807891",
          "3010703925",
          "8010762",
          "9611109",
          "1828100",
          "3005941719",
          "3007427881",
          "3011554160",
          "2916596",
          "3001589655",
          "2184009",
          "9680841",
          "3006073153",
          "1218444",
          "3042990265",
          "3010163695",
          "3002807090",
          "3009507273"
        ],
        "fei_number": [
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          "3010703925",
          "3006003617",
          "1828100",
          "3007427881",
          "3011554160",
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          "2916596",
          "3005426550",
          "1000116158",
          "3009649876",
          "3002808267",
          "3006073153",
          "3002807111",
          "1218444",
          "3042990265",
          "3010163695",
          "3009507273"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}