{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48461",
      "product_res_number": "Z-0307-2007",
      "event_date_initiated": "2006-11-10",
      "event_date_posted": "2006-12-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-06-19",
      "res_event_number": "36349",
      "product_code": "DTQ",
      "product_description": "Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).",
      "code_info": "All units Serial numbers 0006 through 0213.",
      "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": "Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.",
      "root_cause_description": "Other",
      "action": "A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual.  Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.",
      "product_quantity": "208",
      "distribution_pattern": "Worldwide, including USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",
      "openfda": {
        "k_number": [
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          "K861388",
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        ],
        "registration_number": [
          "9611109",
          "3019807891",
          "3002807090",
          "1828100",
          "3011554160",
          "3007427881",
          "8010762",
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          "3010703925",
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        "fei_number": [
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          "3006073153",
          "3001589655",
          "3006003617",
          "1218444",
          "2916596",
          "3002808267"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}