{
  "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": "2026-04-15",
    "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": "81164",
      "recalling_firm": "OriGen Biomedical, Inc.",
      "address_1": "7000 Burleson Rd Bldg D",
      "address_2": "",
      "postal_code": "78744-3202",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI    OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom",
      "recall_number": "Z-0269-2019",
      "product_description": "REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473     Product Usage:  The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.",
      "product_quantity": "134",
      "reason_for_recall": "Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage",
      "recall_initiation_date": "20150330",
      "center_classification_date": "20181107",
      "termination_date": "20240301",
      "report_date": "20181114",
      "code_info": "Product Code UDI                         Lot  VV19F         00816203022097 N18394",
      "more_code_info": ""
    }
  ]
}