{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "198187",
      "product_res_number": "Z-1193-2023",
      "event_date_initiated": "2023-02-10",
      "event_date_posted": "2023-03-01",
      "recall_status": "Open, Classified",
      "res_event_number": "91564",
      "product_code": "JAF",
      "k_numbers": [
        "K904392"
      ],
      "product_description": "MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01",
      "code_info": "All Serial Numbers",
      "firm_fei_number": "1222117",
      "recalling_firm": "Unetixs Vascular, Inc.",
      "address_1": "333 Strawberry Field Rd Ste 11 333 Strawberry Field Rd",
      "address_2": "Ste 11",
      "city": "Warwick",
      "state": "RI",
      "postal_code": "02886-2459",
      "additional_info_contact": "Mr. John Haefele\n401-583-0089",
      "reason_for_recall": "The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.",
      "root_cause_description": "Use error",
      "action": "Urgent Medical Device Notification letters were sent to customers beginning 2/10/23.\n\nIn order to physically prevent device misconnections from occurring, standardized connector designs for specific medical applications have been developed in accordance with ISO-80369-5. Unetixs Vascular has adopted this standard and ceased shipment of devices, hoses and blood pressure accessories equipped with luer fittings. All new devices will ship with bayonet connectors. These new connectors are designed to help reduce the risk for medical device misconnection.\n\nAction Items:\n1. Immediately order one Bayonet Conversion Kit (BCK) per device via our website, www.unetixs.com/shop, to replace every air tubing connector on the device.\n2. Complete the enclosed recall return response form. There is no need to return any product/accessories to Unetixs Vascular.\n\nThank you for your attention to this matter. Unetixs Vascular is committed to providing high-quality products and partnering with you to ensure the safety of each patient. Please address any questions you may have with your local Sales Representative or our customer service department at 800-486-3849. If you are no longer in possession of this device, please ensure this notification gets to the current user.\n\nPlease visit the following link for additional Examples of Medical Device Misconnections:\n\nhttps://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections",
      "product_quantity": "1706 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and Global distribution.",
      "openfda": {
        "k_number": [
          "K982635",
          "K973644",
          "K854590",
          "K110628",
          "K063600",
          "K822602",
          "K093393",
          "K010521",
          "K973857",
          "K851149",
          "K942441",
          "K800768",
          "K780200",
          "K943200",
          "K935427",
          "K081429",
          "K944196",
          "K242487",
          "K844128",
          "K852572",
          "K912925",
          "K141657",
          "K780201",
          "K060064",
          "K973336",
          "K900882",
          "K912033",
          "K904392",
          "K800096",
          "K052067",
          "K800097",
          "K090009",
          "K943338",
          "K842408",
          "K843933",
          "K854591",
          "K882018",
          "K070815"
        ],
        "registration_number": [
          "3007708502",
          "1000589001",
          "3006680097",
          "1216677",
          "3030151584",
          "2183319",
          "9611033",
          "3006265099",
          "1937397",
          "1222117",
          "3010611950"
        ],
        "fei_number": [
          "3007708502",
          "1000589001",
          "3002807138",
          "3006680097",
          "1216677",
          "3030151584",
          "2183319",
          "3006265099",
          "1937397",
          "1222117",
          "3010611950"
        ],
        "device_name": "Monitor, Ultrasonic, Nonfetal",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1540",
        "device_class": "2"
      }
    }
  ]
}