{
  "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": "48583",
      "product_res_number": "Z-0330-2007",
      "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 Level Detection; Catalog number 802111.",
      "code_info": "Serial numbers 00023, 00025 through 00027, 00055, 00061 through 00081, 00083 through 00099, 00101 through 00109, 00111 through 00183, 00185 through 00260, 00262 through 00269. 00271 through 00293, 00295 through 00307 and 00309 through 00357.",
      "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": "4,740 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",
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          "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"
      }
    }
  ]
}