{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139610",
      "product_res_number": "Z-0123-2016",
      "event_date_initiated": "2015-01-05",
      "event_date_posted": "2015-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-04-21",
      "res_event_number": "72018",
      "product_code": "OQY",
      "k_numbers": [
        "K150573"
      ],
      "product_description": "The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY.\r\nIntended for use in providing temporary control or reduction of postpartum uterine bleeding.",
      "code_info": "Manufacturing lot 1214-F-403 and 1214-V-424",
      "firm_fei_number": "1000220650",
      "recalling_firm": "Clinical Innovations, LLC",
      "address_1": "747 W 4170 S",
      "city": "Murray",
      "state": "UT",
      "postal_code": "84123-1364",
      "additional_info_contact": "Thomas D. Haueter\n801-268-8200",
      "reason_for_recall": "Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.",
      "root_cause_description": "Other",
      "action": "Consignees were notified via email on 08/21/15.  All consignees were asked to acknowledge the recall and return devices.",
      "product_quantity": "827 units",
      "distribution_pattern": "Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.",
      "openfda": {
        "k_number": [
          "K212757",
          "K150573",
          "K170622",
          "K091958",
          "K101535",
          "K223098",
          "K230849",
          "K191264",
          "K201199",
          "K253642",
          "K153591"
        ],
        "registration_number": [
          "1718873",
          "1216677",
          "2025851",
          "3010419931",
          "3014279513",
          "1721676",
          "1820334",
          "3030447506",
          "3014718111",
          "1825146"
        ],
        "fei_number": [
          "1718873",
          "1216677",
          "1000121355",
          "2025851",
          "3010419931",
          "3014279513",
          "1721676",
          "1820334",
          "3030447506",
          "1825146"
        ],
        "device_name": "Intrauterine Tamponade Balloon",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4530",
        "device_class": "2"
      }
    }
  ]
}