{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "64433",
      "product_res_number": "Z-0671-2009",
      "event_date_initiated": "2007-11-20",
      "event_date_posted": "2009-01-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-08-06",
      "res_event_number": "44850",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802112.\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 00001 through 01246, 01257 through 01277, 01279 through 01286, 01288 through 01295, 01298 through 01308, 01310 through 01315 and 01319 through 01320.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "The system may malfunction due to t-filter corrosion on an internal circuit board.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "U.S. consignees were notified of the problem by letter on 11/16/07. International affiliates were informed via email on 11/21/07.  Consignees were informed that Terumo would schedule appointments to install new pressure modules and reconfigure the systems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the work themselves.  For additional information, contact Terumo CVS Customer Service at 1-800-521-2818.",
      "product_quantity": "1219 (total)",
      "distribution_pattern": "Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.",
      "openfda": {
        "k_number": [
          "K102726",
          "K070213",
          "K011088",
          "K151349",
          "K090006",
          "K002116",
          "K942582",
          "K052555",
          "K103762",
          "K071318",
          "K153376",
          "K943803",
          "K863541",
          "K022947",
          "K221895",
          "K964017",
          "K092463",
          "K021694",
          "K863960",
          "K080832",
          "K190282",
          "K172220",
          "K221373",
          "K982014",
          "K062396",
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          "K133598",
          "K915183",
          "K813034",
          "K862973",
          "K060053",
          "K232291",
          "K801097",
          "K861388",
          "K950990",
          "K131041",
          "K851614",
          "K091007",
          "K770002",
          "K030141",
          "K772001",
          "K210130",
          "K093882",
          "K202125",
          "K842138",
          "K871131",
          "K020571",
          "K173834",
          "K851615"
        ],
        "registration_number": [
          "1828100",
          "3007427881",
          "1218444",
          "3005941719",
          "3002807090",
          "3001589655",
          "2916596",
          "3010163695",
          "3019807891",
          "3011554160",
          "8010762",
          "3042990265",
          "3010703925",
          "3009507273",
          "2184009",
          "3006073153",
          "9680841",
          "9611109"
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        "fei_number": [
          "3005426550",
          "3009649876",
          "3002808267",
          "1828100",
          "3007427881",
          "1218444",
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          "2916596",
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          "3042990265",
          "3010703925",
          "3009507273",
          "3006073153",
          "3002807111",
          "1000116158"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}