{
  "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": "Glens Falls",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76570",
      "recalling_firm": "Angiodynamics Inc. (Navilyst Medical Inc.)",
      "address_1": "10 Glens Falls Tech Park",
      "address_2": "N/A",
      "postal_code": "12801-3864",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia  and Spain.",
      "recall_number": "Z-0248-2018",
      "product_description": "Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883    The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.",
      "product_quantity": "4591 units in total",
      "reason_for_recall": "Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use.  NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.",
      "recall_initiation_date": "20161128",
      "center_classification_date": "20171213",
      "termination_date": "20190612",
      "report_date": "20171220",
      "code_info": "Lot 4908978"
    }
  ]
}