{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30027",
      "product_res_number": "Z-0088-04",
      "event_date_initiated": "2003-10-22",
      "event_date_posted": "2003-11-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-04-05",
      "res_event_number": "27540",
      "product_code": "KZH",
      "k_numbers": [
        "K924607"
      ],
      "product_description": "10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set",
      "code_info": "Catalog/Model number CL-07011, Lot number CF03075226",
      "firm_fei_number": "3015859709",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "city": "Reading",
      "state": "PA",
      "postal_code": "19605-9607",
      "additional_info_contact": "Walter C. Henry\n610-478-3159",
      "reason_for_recall": "package lid identifies the contents incorrectly",
      "root_cause_description": "Other",
      "action": "The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.",
      "product_quantity": "80 units",
      "distribution_pattern": "The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka",
      "openfda": {
        "k_number": [
          "K160860",
          "K033696",
          "K872233",
          "K141384",
          "K000482",
          "K992300",
          "K945660",
          "K954729",
          "K883164",
          "K082587",
          "K032848",
          "K832847",
          "K961309",
          "K991680",
          "K111467",
          "K050434",
          "K063146",
          "K970479",
          "K974678",
          "K993385",
          "K013362",
          "K122837",
          "K981266",
          "K901803",
          "K832683",
          "K060141",
          "K243232",
          "K021700",
          "K945473",
          "K051667",
          "K010377",
          "K062339",
          "K953735",
          "K834440",
          "K862325",
          "K042557",
          "K951384",
          "K124026",
          "K073476",
          "K790104",
          "K974171",
          "K213429",
          "K163400",
          "K032425",
          "K860284",
          "K060389",
          "K870474"
        ],
        "device_name": "Introducer, Syringe Needle",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6920",
        "device_class": "2",
        "registration_number": [
          "9616674",
          "3009566827",
          "1219205",
          "8021545",
          "3013188547",
          "3030446844",
          "3002806818",
          "3007115200",
          "1058602",
          "3008061617",
          "3005831843",
          "3004837462",
          "3002807090",
          "1110315",
          "3002958688",
          "2243072",
          "3004111573",
          "9681821",
          "3002808086",
          "3005581234",
          "3003442380",
          "3014585508",
          "3027031650",
          "3006126537",
          "8021764",
          "3003348846",
          "2244771",
          "2243252",
          "2523167",
          "2032227",
          "2011171",
          "9681538",
          "3013143994",
          "3007207906",
          "9710049",
          "3009327445",
          "3038138498",
          "3003974574",
          "3007020251",
          "3021853802"
        ],
        "fei_number": [
          "3009566827",
          "1219205",
          "3004483565",
          "3013188547",
          "3030446844",
          "3002806818",
          "3003131673",
          "3003166194",
          "3008061617",
          "3005831843",
          "1000219614",
          "3004837462",
          "1110315",
          "3003346138",
          "3002958688",
          "2243072",
          "3004111573",
          "3002808086",
          "3005581234",
          "3003442380",
          "3014585508",
          "3002806521",
          "3027031650",
          "3006126537",
          "3003348846",
          "2244771",
          "3006003617",
          "3000191104",
          "2243252",
          "2523167",
          "2011171",
          "3013143994",
          "3007207906",
          "3009327445",
          "3038138498",
          "1000477110",
          "3003974574",
          "3002808103",
          "3007020251",
          "3021853802"
        ]
      }
    }
  ]
}