{
  "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": "2026-04-01",
    "results": {
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      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88808",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution worldwide.",
      "recall_number": "Z-0223-2022",
      "product_description": "Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS.  GPN G19261.     Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle",
      "product_quantity": "4789 (OUS only)",
      "reason_for_recall": "Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.",
      "recall_initiation_date": "20211008",
      "center_classification_date": "20211112",
      "termination_date": "20240214",
      "report_date": "20211124",
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