{
  "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 units",
      "code_info": "Product Code  Lot Number  UDI Number  Quantity  HAL545  50137556  (01)00801741111549(17)170331(10)50137556  95  HAL545  50137557  (01)00801741111549(17)170331(10)50137557  95  HAL545  50137598  (01)00801741111549(17)170331(10)50137598  95  HAL545  50137682  (01)00801741111549(17)170331(10)50137682  95  HAL545  50137723  (01)00801741111549(17)170331(10)50137723  95  HAL545  50137735  (01)00801741111549(17)170331(10)50137735  95  HAL545  50137875  (01)00801741111549(17)170331(10)50137875  95  HAL545  50137965  (01)00801741111549(17)170331(10)50137965  96  HAL545  50138274  (01)00801741111549(17)170331(10)50138274  95  HAL545  50138119  (01)00801741111549(17)170331(10)50138119  95  HAL545  50138118  (01)00801741111549(17)170331(10)50138118  95  HAL545  50138122  (01)00801741111549(17)170331(10)50138122  95  HAL545  50138273  (01)00801741111549(17)170331(10)50138273  95  HAL545  50138435  (01)00801741111549(17)170430(10)50138435  84  HAL545  50138437  (01)00801741111549(17)170430(10)50138437  95  HAL545  50138701  (01)00801741111549(17)170430(10)50138701  95  HAL545  50138439  (01)00801741111549(17)170430(10)50138439  95",
      "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 45 cm  Product Code: HAL545  The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature",
      "report_date": "20170125",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "BARD PERIPHERAL VASCULAR, INC",
      "recall_number": "Z-0968-2017",
      "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"
    }
  ]
}