{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Garland",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96622",
      "recalling_firm": "Galt Medical Corporation",
      "address_1": "2220 Merritt Dr",
      "address_2": "N/A",
      "postal_code": "75041-6137",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.",
      "recall_number": "Z-1733-2025",
      "product_description": "B Braun Interventional ELITE HV Hemostasis Valve Introducer System  REF 612802  Model Number: BCL-100-04    The Elite HV¿ Introducer System is indicated for use in percutaneous  procedures to introduce catheters and other intravascular devices into the  vasculature.",
      "product_quantity": "100 systems",
      "reason_for_recall": "Due to a potential open seal in the sterile barrier packaging .",
      "recall_initiation_date": "20250327",
      "center_classification_date": "20250507",
      "report_date": "20250514",
      "code_info": "Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171",
      "more_code_info": ""
    }
  ]
}