{
  "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": "2026-08-15",
    "results": {
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  "results": [
    {
      "cfres_id": "103985",
      "product_res_number": "Z-0053-2012",
      "event_date_initiated": "2011-09-13",
      "event_date_posted": "2011-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-10",
      "res_event_number": "59912",
      "product_code": "DTS",
      "product_description": "Sarns Rigid Intracardiac Sucker.  \nThe subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector",
      "code_info": "Catalog number 4300 and CV-4300",
      "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": "800-521-2818",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns\" Adult Rigid Intracardiac Sucker.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On  9/13/2011 Terumo sent a letter entitled \"URGENT MEDICAL DEVICE REMOVAL\" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions.  Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned.  Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.",
      "product_quantity": "9770",
      "distribution_pattern": "Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.",
      "openfda": {
        "k_number": [
          "K801400",
          "K791846",
          "K900339",
          "K905008",
          "K053021",
          "K963756",
          "K801641",
          "K891906",
          "K982891"
        ],
        "registration_number": [
          "1422634",
          "1625519",
          "3005213560",
          "1836161",
          "1724474",
          "1643817",
          "3014247825",
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          "3003944071",
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          "3005426550",
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          "1721676"
        ],
        "device_name": "Sucker, Cardiotomy Return, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4420",
        "device_class": "2"
      }
    }
  ]
}