{
  "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": "48591",
      "product_res_number": "Z-0333-2007",
      "event_date_initiated": "2004-10-12",
      "event_date_posted": "2006-12-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-01",
      "res_event_number": "36396",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018.",
      "code_info": "Serial numbers 00017, 00020, 00023 through 00026, 00029 through 00031, 00033, 00034, 00036 through 00048, 00051 through 00055, 00057 through 00078, 00080 through 00120, 00122 through 00134, 00136, 00138 through 00155, 00158 through 00169, 00171 through 00210, 00212 through 00243 and 00248.",
      "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": "Device module(s) may fail to properly initialize during start up, thus resulting in that  single module being inoperable and a red 'X' being displayed on the monitor screen.",
      "root_cause_description": "Other",
      "action": "U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error.  International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.",
      "product_quantity": "4740 for all affected products",
      "distribution_pattern": "Worldwide Distribution-USA and countries 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": [
          "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",
          "K030141",
          "K070213",
          "K091007",
          "K020571",
          "K163531",
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          "K062396",
          "K103762",
          "K002118",
          "K863541",
          "K982014",
          "K102726",
          "K022947",
          "K942582",
          "K770002",
          "K232291",
          "K153376",
          "K221895",
          "K964017",
          "K202125",
          "K950990",
          "K172220",
          "K131041",
          "K851614",
          "K093882"
        ],
        "registration_number": [
          "2916596",
          "9680841",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "2184009",
          "1218444",
          "8010762",
          "9611109",
          "3019807891",
          "3006073153",
          "3002807090",
          "3010703925",
          "3009507273",
          "3005941719",
          "3011554160",
          "3001589655"
        ],
        "fei_number": [
          "2916596",
          "1000116158",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "1218444",
          "3002808267",
          "3019807891",
          "3006073153",
          "3010703925",
          "3009649876",
          "3006003617",
          "3002807111",
          "3009507273",
          "3011554160",
          "3001589655",
          "3005426550"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}