{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Glens Falls",
      "address_1": "10 Glens Falls Tech Park",
      "reason_for_recall": "PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.",
      "address_2": "",
      "product_quantity": "100 units",
      "code_info": "Batch/Lots: 4759481, 4807952, 4746868, 4752404 & 4788361.   Use By 2015-08-31",
      "center_classification_date": "20160614",
      "distribution_pattern": "Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.",
      "state": "NY",
      "product_description": "Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV 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 and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring",
      "report_date": "20160622",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Navilyst Medical, Inc., an AngioDyamics Company",
      "recall_number": "Z-1978-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73598",
      "termination_date": "20180611",
      "more_code_info": "",
      "recall_initiation_date": "20160314",
      "postal_code": "12801-3864",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}