{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "25078",
      "product_res_number": "Z-0408-03",
      "event_date_initiated": "2002-11-08",
      "event_date_posted": "2003-05-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-04-15",
      "res_event_number": "25052",
      "product_code": "FIE",
      "k_numbers": [
        "K002813"
      ],
      "product_description": "The following brand name labeled products are under recall (all \ncatalog numbers and all lot numbers under recall):\nNIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula \nSet and EXEL Secure Touch Safety AV Fistula Needle Set.",
      "code_info": "All lot numbers in current distribution are under recall.",
      "firm_fei_number": "1000132332",
      "recalling_firm": "Nipro Corp",
      "address_1": "3150 NW 107th Avenue Brokers",
      "address_2": "Box 97",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33172",
      "reason_for_recall": "Air or fluid leakage at the hub/needle junction.",
      "root_cause_description": "Other",
      "action": "The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level.  It was requested that Nipro be notified of all held and recovered product for pickup.  Also new replacement product will be made available in the near future.",
      "product_quantity": "6,984,000",
      "distribution_pattern": "Nationwide and Canada",
      "openfda": {
        "k_number": [
          "K001496",
          "K782021",
          "K063721",
          "K862002",
          "K770699",
          "K910734",
          "K772362",
          "K844343",
          "K801618",
          "K142564",
          "K131950",
          "K791489",
          "K771491",
          "K063368",
          "K771490",
          "K112734",
          "K891062",
          "K163025",
          "K990803",
          "K900125",
          "K801966",
          "K851453",
          "K771492",
          "K990470",
          "K093637",
          "K970962",
          "K253469",
          "K110157",
          "K832136",
          "K955182",
          "K051814",
          "K911199",
          "K771495",
          "K093985",
          "K771493",
          "K902564",
          "K151017",
          "K854773",
          "K013384",
          "K812621",
          "K134019",
          "K112178",
          "K990510",
          "K903945",
          "K854951",
          "K771494",
          "K002352",
          "K111948",
          "K811838",
          "K992653",
          "K000843",
          "K915174",
          "K945850",
          "K171505",
          "K002813",
          "K801632",
          "K003123",
          "K993118",
          "K802956",
          "K062953",
          "K791490",
          "K860449",
          "K860789",
          "K903440",
          "K023162",
          "K860241",
          "K082882",
          "K880726",
          "K771206",
          "K013037",
          "K991623",
          "K932074",
          "K213015",
          "K052267",
          "K040247",
          "K251877",
          "K770864",
          "K974902",
          "K100520",
          "K000845"
        ],
        "device_name": "Needle, Fistula",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
          "3013671177",
          "3010187826",
          "3013217742",
          "3032143970",
          "3003895440",
          "3003464075",
          "3010131137",
          "2028632",
          "3002807350",
          "8041145",
          "3010413216",
          "3000247873",
          "3010273867",
          "2032098",
          "9615908",
          "1056186",
          "2029275",
          "9616419"
        ],
        "fei_number": [
          "3013671177",
          "3010187826",
          "3013217742",
          "3032143970",
          "3003656001",
          "3003895440",
          "3003464075",
          "1000306431",
          "3003058448",
          "3010131137",
          "3002974635",
          "3002807350",
          "3010413216",
          "3000247873",
          "3010273867",
          "1000125025",
          "3003282181",
          "1000132332"
        ]
      }
    }
  ]
}