{
  "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,
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  },
  "results": [
    {
      "cfres_id": "105472",
      "product_res_number": "Z-0840-2012",
      "event_date_initiated": "2012-01-13",
      "event_date_posted": "2012-01-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-03",
      "res_event_number": "60463",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Roller Pump, 6 Inch Diameter\n\nThe Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.",
      "code_info": "Catalog Number 816571; Serial Numbers 6621 - 6640",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "Tracy Bellanca\n734-741-6056",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4\" and the 6\" roller pumps for the Terumo Advanced Perfusion System 1.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees.  The letter identified the product, the problem, and the action to be taken by the consignee.  Consignees were instructed to review the Medical Device Correction notice.  Assure that all users are aware of the notice.  Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551.  Roller pumps with affected cables will have the cables assembly replaced.\n\nFor questions regarding this recall call 1-800-521-2818.",
      "product_quantity": "44",
      "distribution_pattern": "Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam",
      "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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          "K070213",
          "K091007",
          "K020571",
          "K163531",
          "K772001",
          "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",
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          "3006073153",
          "3002807090",
          "3010703925",
          "3009507273",
          "3005941719",
          "3011554160",
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        "fei_number": [
          "2916596",
          "1000116158",
          "3007427881",
          "1828100",
          "3010163695",
          "3042990265",
          "1218444",
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          "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"
      }
    }
  ]
}