{
  "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  HAL510F  50137866  (01)00801741129698(17)170331(10)50137866  58  HAL510F  50137924  (01)00801741129698(17)170331(10)50137924  73  HAL510F  50138170  (01)00801741129698(17)170331(10)50138170  89  HAL510F  50138765  (01)00801741129698(17)170531(10)50138765  27",
      "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 10 cm 5 pack  Product Code: HAL510F    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-0970-2017",
      "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"
    }
  ]
}