{
  "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": "48585",
      "product_res_number": "Z-0331-2007",
      "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 Pressure Monitoring; Catalog number 802112.",
      "code_info": "Serial numbers 00017 through 00032, 00036, 00043, 00045 through 00057, 00059 through 00062, 00065 through 00071, 00073 through 00079, 00081 through 00099, 00102 through 00122, 00125 through 000251, 00253 through 00292, 00296 through 00309, 00311 through 00349, 00352 through 00479, 00484 and  00489.",
      "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": [
          "K870976",
          "K022947",
          "K221373",
          "K172220",
          "K942582",
          "K091007",
          "K133598",
          "K002116",
          "K915183",
          "K232291",
          "K801097",
          "K842138",
          "K093882",
          "K102726",
          "K822068",
          "K982014",
          "K863541",
          "K851615",
          "K080832",
          "K772001",
          "K163531",
          "K221895",
          "K770002",
          "K813034",
          "K210130",
          "K950990",
          "K871131",
          "K090006",
          "K103762",
          "K173834",
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          "K202125",
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          "K062396",
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          "K021694",
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          "K020571",
          "K964017",
          "K030141",
          "K862973",
          "K131041",
          "K851614",
          "K011088",
          "K863960",
          "K861388",
          "K943803",
          "K052555",
          "K092463",
          "K151349",
          "K190282"
        ],
        "registration_number": [
          "9611109",
          "3019807891",
          "3002807090",
          "1828100",
          "3011554160",
          "3007427881",
          "8010762",
          "3042990265",
          "3009507273",
          "3010163695",
          "3006073153",
          "3001589655",
          "3010703925",
          "1218444",
          "3005941719",
          "2916596",
          "9680841",
          "2184009"
        ],
        "fei_number": [
          "3010703925",
          "3019807891",
          "1828100",
          "3011554160",
          "3007427881",
          "3009649876",
          "3042990265",
          "3002807111",
          "3009507273",
          "3010163695",
          "3005426550",
          "1000116158",
          "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"
      }
    }
  ]
}