{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "53816",
      "product_res_number": "Z-0323-2008",
      "event_date_initiated": "2007-09-10",
      "event_date_posted": "2007-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-07-07",
      "res_event_number": "38467",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103",
      "code_info": "Serial Numbers 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176.",
      "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": "Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.",
      "root_cause_description": "Component change control",
      "action": "Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.",
      "product_quantity": "120",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K842138",
          "K011088",
          "K052555",
          "K813034",
          "K863960",
          "K090006",
          "K822068",
          "K133598",
          "K021694",
          "K210130",
          "K861388",
          "K002116",
          "K071318",
          "K173834",
          "K943803",
          "K871131",
          "K221373",
          "K862973",
          "K851615",
          "K080832",
          "K870976",
          "K801097",
          "K915183",
          "K151349",
          "K060053",
          "K092463",
          "K190282",
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          "K202125",
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        "registration_number": [
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          "9680841",
          "3007427881",
          "1828100",
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          "3042990265",
          "2184009",
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        "fei_number": [
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          "3006003617",
          "3002807111",
          "3009507273",
          "3011554160",
          "3001589655",
          "3005426550"
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        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}