{
  "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": [
    {
      "country": "United States",
      "city": "Tempe",
      "address_1": "1415 W 3rd St",
      "reason_for_recall": "Complaints of sheath separation, kinking, and/or tip damage during use.",
      "address_2": "",
      "product_quantity": "101",
      "code_info": "Product Code  Lot Number  UDI Number  Quantity  HAL590  50137570  (01)00801741111525(17)170331(10)50137570  95  HAL590  50137770  (01)00801741111525(17)170331(10)50137770  79  HAL590  50137979  (01)00801741111525(17)170331(10)50137979  95  HAL590  50138696  (01)00801741111525(17)170430(10)50138696  23",
      "center_classification_date": "20170118",
      "distribution_pattern": "Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH.    No foreign distribution.",
      "state": "AZ",
      "product_description": "Halo One 5F Introducer Sheath 90 cm  Product Code: HAL590      Product Usage:  The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.",
      "report_date": "20170125",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "BARD PERIPHERAL VASCULAR, INC",
      "recall_number": "Z-0969-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75875",
      "termination_date": "20170405",
      "more_code_info": "",
      "recall_initiation_date": "20161202",
      "postal_code": "85281-7634",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}