{
  "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": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78033",
      "recalling_firm": "OriGen Biomedical, Inc.",
      "address_1": "7000 Burleson Rd Bldg D",
      "address_2": "N/A",
      "postal_code": "78744-3202",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.",
      "recall_number": "Z-0021-2018",
      "product_description": "The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.",
      "product_quantity": "180 units",
      "reason_for_recall": "Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO  Catheter has had a separation of the clear extension tube from the hub connection. These  adverse events resulted in patient injury (blood loss).",
      "recall_initiation_date": "20170802",
      "center_classification_date": "20171020",
      "termination_date": "20240229",
      "report_date": "20171101",
      "code_info": "Lot Numbers:  N18487, N18487-1"
    }
  ]
}