{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Greensboro",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80539",
      "recalling_firm": "ConvaTec, Inc",
      "address_1": "7900 Triad Center Dr Ste 400",
      "address_2": "",
      "postal_code": "27409-9076",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Canada, Bahrain, Bangladesh, Belgium, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Kenya, Kuwait, Malta, Mauritius, Netherlands,Norway, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.",
      "recall_number": "Z-2744-2018",
      "product_description": "AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301     AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.",
      "product_quantity": "3881 units",
      "reason_for_recall": "Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.",
      "recall_initiation_date": "20180703",
      "center_classification_date": "20180810",
      "termination_date": "20230124",
      "report_date": "20180822",
      "code_info": "a) ABV 300: Lot Number 150924  b) ABV 301: Lot Numbers:  160937, 161023, 161128, 170120, 170514, 170732, 170801, 170829",
      "more_code_info": ""
    }
  ]
}