{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Morrisville",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89390",
      "recalling_firm": "TELEFLEX MEDICAL INC",
      "address_1": "3015 Carrington Mill Blvd",
      "address_2": "N/A",
      "postal_code": "27560-5437",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.",
      "recall_number": "Z-0623-2022",
      "product_description": "Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components:  PT-12709-CA, PT-12709-C,     The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.",
      "product_quantity": "676 units",
      "reason_for_recall": "The firm received reports indicating PTD tip separation during use.",
      "recall_initiation_date": "20220111",
      "center_classification_date": "20220215",
      "termination_date": "20240911",
      "report_date": "20220223",
      "code_info": "Lot Number / UDI:  13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873;   Lot Number / UDI:  13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components:  Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873;   Lot Number / UDI:  13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components:  Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585;  Lot Number / UDI:  13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components:  Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872;   Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components:  Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144;   Lot Number / UDI:  13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components:  Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144;   Lot Number / UDI:  13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components:  Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413;   Lot Number / UDI:  13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components:  Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007"
    }
  ]
}