{
  "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-0626-2022",
      "product_description": "Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components:   PT-65709-C, PT-03009, PT-65709-HS    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": "1874 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: 13F20C0596 / (01)10801902121308 (17)220331 (10)13F20C0596, Components:  Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20B1435; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C20C1558;   Lot Number / UDI: 13F20F0081 / (01)10801902121308 (17)220531 (10)13F20F0081, Components:  Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C20C1558;   Lot Number / UDI: 13F20F0229 / (01)10801902121308 (17)220531 (10)13F20F0229, Components:  Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F0570; Code PT-03009, Lot number 13C20C1558;   Lot Number / UDI: 13F20F0509 / (01)10801902121308 (17)220531 (10)13F20F0509, Components:  Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20F0570;   Lot Number / UDI: 13F20F0578 / (01)10801902121308 (17)220630 (10)13F20F0578, Components:  Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HS, Lot number 14C20D1061; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20F1138;   Lot Number / UDI: 13F20G0177 / (01)10801902121308 (17)220630 (10)13F20G0177, Components:  Code PT-65709-C, Lot number 13C20G0228; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20G0238   Lot Number / UDI: 13F20G0566 / (01)10801902121308 (17)220630 (10)13F20G0566, Components:  Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0864; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585;   Lot Number / UDI: 13F20H0531 / (01)10801902121308 (17)220831 (10)13F20H0531, Components:  Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20G0395; Code PT-03009, Lot number 13C20G1198; Code PT-03009, Lot number 13C20G0864;   Lot Number / UDI: 13F20J0379 / (01)10801902121308 (17)220831 (10)13F20J0379, Components:  Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20H0604;   Lot Number / UDI: 13F20L0514 / (01)10801902121308 (17)221031 (10)13F20L0514, Components:  Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HS, Lot number 14C20H0384; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20L0871; Code PT-03009, Lot number 13C20L0872;   Lot Number / UDI: 13F21A0354 / (01)10801902121308 (17)221231 (10)13F21A0354, Components:  Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144;   Lot Number / UDI: 13F21C0081 / (01)10801902121308 (17)230228 (10)13F21C0081, Components:  Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21B1533; Code PT-03009, Lot number 13C21A0855;   Lot Number / UDI: 13F21C0749 / (01)10801902121308 (17)230331 (10)13F21C0749, Components:  Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 13C21C1696; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533;   Lot Number / UDI: 13F21D0870 / (01)10801902121308 (17)230430 (10)13F21D0870, Components:  Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21C0327;   Lot Number / UDI: 13F21E0415 / (01)10801902121308 (17)230430 (10)13F21E0415, Components:  Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21C0476; Code PT-65709-HS, Lot number 14C21B0690; Code PT-03009, Lot number 13C21C2397; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533;   Lot Number / UDI: 13F21F1188 / (01)10801902121308 (17)230630 (10)13F21F1188, Components:  Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21E0722"
    }
  ]
}