{
  "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": "148047",
      "product_res_number": "Z-0057-2017",
      "event_date_initiated": "2016-07-01",
      "event_date_posted": "2016-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-04-14",
      "res_event_number": "74614",
      "product_code": "DTN",
      "k_numbers": [
        "K981284"
      ],
      "product_description": "The Better-Bladder With 14\" ID tubing, ITEM BB14, STERILE,\n\nMeasure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.",
      "code_info": "Lot Numbers: R19229, 015323, 014882, 014602 & 014601",
      "firm_fei_number": "1000522036",
      "recalling_firm": "Circulatory Technology Inc",
      "address_1": "21 Singworth St",
      "city": "Oyster Bay",
      "state": "NY",
      "postal_code": "11771-3703",
      "additional_info_contact": "Yehuda Tamari\n516-624-2424",
      "reason_for_recall": "Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.",
      "root_cause_description": "Use error",
      "action": "The firm, Circulatory Technology Inc., sent an \"Urgent: Device Recall\" letter dated July 1, 2016 and response forms to their customers via email.  The letter described the product, problem and actions to be taken. The letter instructed  customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine.  Customers were also advised to complete and return the response form via email to ytamari@cirtec.com.  \n\nCustomers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.",
      "product_quantity": "958 units",
      "distribution_pattern": "US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.",
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        "device_name": "Reservoir, Blood, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4400",
        "device_class": "2"
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}