{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204211",
      "product_res_number": "Z-0554-2024",
      "event_date_initiated": "2023-11-15",
      "event_date_posted": "2023-12-14",
      "recall_status": "Open, Classified",
      "res_event_number": "93375",
      "product_code": "EXS",
      "product_description": "Sensica Urine Output System, Catalog Number SCCS1002",
      "code_info": "UDI/DI 00801741215773, Serial numbers:  BMGPRMYS001\t, BMGPRMYS003, BMGPRMYS004, BMGPRMYS005, BMGPRMYS006, BMGPRMYS007, BMGPRMYS020, BMGPRMYS026, BMGPRMYS028, BMGPRMYS030, BMFWRMSBT4, BMFWRMSJ45, BMFWRMSJ49, BMFZRMS104, BMGNRMS085, BMFSRMSH98, BMFSRMSJ01, BMFVRMSQ62, BMFVRMSQ66, BMFVRMSQ68, BMFYRMSJ41, BMFYRMSJ49, BMFZRMS067, BMFZRMS070, BMFZRMS080, BMFZRMS113, BMFZRMS117, BMGNRMS070, BMFURMSF02, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ89, BMFVRMSQ91, BMFWRSJ46, BMGPRMYS011, BMGPRMYS018, BMGPRMYS022\t, BMGPRMYS023, BMGPRMYS027, BMFYRMSJ35, BMFYRMSJ37, BMFYRMSJ54, BMFYRMSJ58, BMGNRMS079, BMGNRMSG69, BMGNRMSG74, BMFSRMSH94, BMFSRMSH99, BMFSRMSJ38, BMFSRMSJ44, BMFTRMS138, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFQRMS248, BMFQRMS250, BMFRRMS646, BMFRRMS647, BMGPRMYS008, BMGPRMYS009, BMGPRMYS010, BMGPRMYS013, BMGPRMYS014, BMGPRMYS016, BMFZRMS073, BMFSRMSH78, BMFSRMSH79, BMFSRMSH80, BMFSRMSH81, BMFSRMSH82, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSJ15, BMFQRMS246, BMFWRMSJ39, BMFWRMSJ41, BMFSRMSJ36, BMFSRMSJ37, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS114, BMFTRMS142, BMFURMSF01, BMFURMSF05, BMFSRMSH95, BMFSRMSH97, BMFTRMS120, BMFTRMS122, BMFTRMS123, BMFTRMS135, BMFTRMS136, BMFTRMS137, BMGPRMYS002, BMGPRMYS012, BMGPRMYS019\t, BMGPRMYS029, BMFPRMYS009, BMFQRMS244, BMFQRMS272, BMFQRMS276, BMFQRMS286, BMFQRMS293, BMFSRMSJ43, BMFTRMS121, BMGNRMS067, BMGNRMS076, BMFVRMSQ58, BMFVRMSQ70, BMFVRMSQ73, BMFVRMSQ74, BMFVRMSQ90, BMFVRMSR17, BMFWRMSJ27, BMFWRMSJ35, BMFURMSF06, BMFURMSF09, BMFWRMSJ36, BMFWRMSJ51, BMFZRMS068, BMFQRMS294, BMFZRMS105, BMFSRMSJ20, BMFTRMS140, BMFVRMSQ63, BMFVRMSQ64, BMFVRMSQ65, BMFVRMSQ72, BMFVRMSQ75, BMFVRMSQ76, BMFVRMSQ77, BMFVRMSQ78, BMFVRMSQ80, BMFYRMSJ39, BMFZRMS081, BMFZRMS116, BMGNRMS015, BMGNRMS029, BMGNRMS073",
      "firm_fei_number": "1018233",
      "recalling_firm": "C.R. Bard Inc",
      "address_1": "8195 Industrial Blvd Ne",
      "city": "Covington",
      "state": "GA",
      "postal_code": "30014-1497",
      "additional_info_contact": "North American Regional Complaint Center\n844-823-5433",
      "reason_for_recall": "BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.",
      "root_cause_description": "Under Investigation by firm",
      "action": "BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email.  The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.",
      "product_quantity": "148 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "device_name": "Urinometer, Electrical",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1800",
        "device_class": "2",
        "registration_number": [
          "1018233",
          "3006082230",
          "3013041594",
          "3045857305",
          "3007829657",
          "9610816",
          "3000126629",
          "9611590"
        ],
        "fei_number": [
          "3002807167",
          "1018233",
          "3006082230",
          "3045857305",
          "3013041594",
          "3007829657",
          "3000126629",
          "1000237915"
        ]
      }
    }
  ]
}