{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
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  "results": [
    {
      "country": "United States",
      "city": "Raynham",
      "address_1": "325 Paramount Drive",
      "reason_for_recall": "Incorrect instructions for use (IFU).",
      "address_2": "",
      "product_quantity": "7,983",
      "code_info": "All lot codes",
      "center_classification_date": "20140123",
      "distribution_pattern": "Worldwide Distribution:  US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.",
      "state": "MA",
      "product_description": "TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System:  One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder  Product Code: 631-500      The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.",
      "report_date": "20140129",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Codman & Shurtleff, Inc.",
      "recall_number": "Z-0789-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66493",
      "termination_date": "20150728",
      "more_code_info": "",
      "recall_initiation_date": "20131011",
      "postal_code": "02767",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
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}