{
  "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": "Mississauga",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85353",
      "recalling_firm": "Baylis Medical Company Inc.",
      "address_1": "2645 Matheson Blvd E",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Product distributed throughout the 50 states and in Washington D.C.",
      "recall_number": "Z-2070-2020",
      "product_description": "NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.",
      "product_quantity": "Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).",
      "reason_for_recall": "There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.",
      "recall_initiation_date": "20191007",
      "center_classification_date": "20200521",
      "termination_date": "20210630",
      "report_date": "20200527",
      "code_info": "All lot numbers of the following kit model numbers: NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N, and NTK-711-8555N."
    }
  ]
}