{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "67168",
      "product_res_number": "Z-0311-2009",
      "event_date_initiated": "2008-01-13",
      "event_date_posted": "2008-12-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-07-07",
      "res_event_number": "46314",
      "product_code": "DTQ",
      "product_description": "Terumo Sarns Level Sensor II Pads.  For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900.  Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240.\n\nLevel Sensor pads are used to attach the level sensor \t \nto the sides of a rigid reservoir.",
      "code_info": "Lot Number 78925.",
      "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": "The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.",
      "product_quantity": "31,980 pads (25,620 to U.S. and 6,360 international)",
      "distribution_pattern": "Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.",
      "openfda": {
        "k_number": [
          "K080832",
          "K813034",
          "K202125",
          "K221373",
          "K942582",
          "K002116",
          "K103762",
          "K030141",
          "K915183",
          "K060053",
          "K964017",
          "K011088",
          "K052555",
          "K002118",
          "K153376",
          "K210130",
          "K851614",
          "K090006",
          "K172220",
          "K020571",
          "K842138",
          "K070213",
          "K943803",
          "K851615",
          "K861388",
          "K772001",
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          "K092463",
          "K870976",
          "K093882",
          "K190282",
          "K163531",
          "K091007",
          "K071318"
        ],
        "registration_number": [
          "3019807891",
          "3010703925",
          "8010762",
          "9611109",
          "1828100",
          "3005941719",
          "3007427881",
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          "2916596",
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          "9680841",
          "3006073153",
          "1218444",
          "3042990265",
          "3010163695",
          "3002807090",
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        ],
        "fei_number": [
          "3019807891",
          "3010703925",
          "3006003617",
          "1828100",
          "3007427881",
          "3011554160",
          "3001589655",
          "2916596",
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          "3009649876",
          "3002808267",
          "3006073153",
          "3002807111",
          "1218444",
          "3042990265",
          "3010163695",
          "3009507273"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}