{
  "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": "94171",
      "product_res_number": "Z-0024-2011",
      "event_date_initiated": "2010-10-15",
      "event_date_posted": "2010-10-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-06-29",
      "res_event_number": "56645",
      "product_code": "KRL",
      "product_description": "Air bubble detection cable assembly,  catalog  numbers 78-8067-7375-6 and 149892,  Terumo Cardiovascular System, Ann Arbor, MI",
      "code_info": "all lots of cables distributed prior to 1/4/2008.",
      "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": "734-741-6173",
      "reason_for_recall": "Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. .",
      "root_cause_description": "Other",
      "action": "The firm sent URGENT MEDICAL DEVICE CORRECTION notices dated September 17, 2010.   The notices told consignees that a Terumo representative would visit, inspect the cables and replace the recalled cables. if the customer has a service contract, the visits would occur at the next scheduled preventative maintenance visit. Customers without a service contract will be contacted by Terumo representative to schedule an appointment.\nCustomers can contact Terumo Customer Service  at 800-521-2818.",
      "product_quantity": "5,000 estimated",
      "distribution_pattern": "Worldwide Distribution: USA states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Belgium, Canada, Columbia, Chile, Costa Rica, Germany, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Korea, Mexico, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Taiwan, UAE and Vietnam.",
      "openfda": {
        "k_number": [
          "K090698",
          "K842054",
          "K864619",
          "K803102",
          "K961364",
          "K940651",
          "K071231",
          "K103469",
          "K935977",
          "K961598",
          "K861860",
          "K925661",
          "K911632",
          "K925541"
        ],
        "registration_number": [
          "9681834",
          "8010026",
          "9611109",
          "3008307705",
          "1828100",
          "1649914",
          "1928237"
        ],
        "fei_number": [
          "3008307705",
          "1828100",
          "2828",
          "3002808327",
          "3002808267",
          "3001665800",
          "1928237"
        ],
        "device_name": "Detector, Bubble, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4205",
        "device_class": "2"
      }
    }
  ]
}