{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 184
    }
  },
  "results": [
    {
      "cfres_id": "53878",
      "product_res_number": "Z-0038-2008",
      "event_date_initiated": "2007-06-22",
      "event_date_posted": "2007-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-25",
      "res_event_number": "38511",
      "product_code": "CHL",
      "k_numbers": [
        "K041874"
      ],
      "product_description": "Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.",
      "code_info": "Serial #905-671, 902-754",
      "firm_fei_number": "1523456",
      "recalling_firm": "Radiometer America Inc",
      "address_1": "810 Sharon Dr",
      "city": "Westlake",
      "state": "OH",
      "postal_code": "44145-1598",
      "additional_info_contact": "Vincent Sigmund\n440-871-8900 Ext. 209",
      "reason_for_recall": "Tube may break.  The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly.  These tubes have the potential to break off at the black plastic connectors.  The breakage may occur during the installation of the tubes or after a short time in use.",
      "root_cause_description": "Process design",
      "action": "By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.",
      "product_quantity": "289 pieces",
      "distribution_pattern": "Product was distributed throughout the United States and Canada.",
      "openfda": {
        "k_number": [
          "K990092",
          "K771253",
          "K854608",
          "K770736",
          "K833534",
          "K831025",
          "K962021",
          "K934907",
          "K844295",
          "K974396",
          "K932642",
          "K961335",
          "K812090",
          "K884267",
          "K771147",
          "K200986",
          "K994346",
          "K831012",
          "K760229",
          "K240998",
          "K832779",
          "K935655",
          "K002613",
          "K882941",
          "K051804",
          "K810724",
          "K842519",
          "K200492",
          "K110416",
          "K110648",
          "K852676",
          "K924497",
          "K173403",
          "K884143",
          "K151978",
          "K812552",
          "K122539",
          "K813517",
          "K993789",
          "K823570",
          "K831015",
          "K940918",
          "K050423",
          "K935121",
          "K002290",
          "K820744",
          "K223857",
          "K904513",
          "K954612",
          "K151982",
          "K122642",
          "K833536",
          "K221900",
          "K173797",
          "K021713",
          "K820597",
          "K973367",
          "K936081",
          "K914166",
          "K881188",
          "K000103",
          "K133407",
          "K865036",
          "K974526",
          "K841609",
          "K831020",
          "K945240",
          "K831379",
          "K013729",
          "K853840",
          "K873577",
          "K943643",
          "K924758",
          "K151856",
          "K871397",
          "K922922",
          "K902267",
          "K041874",
          "K021515",
          "K020297",
          "K111897",
          "K955793",
          "K980523",
          "K942616",
          "K760969",
          "K963964",
          "K043218",
          "K992834",
          "K890827",
          "K844781",
          "K122729",
          "K831019",
          "K831018",
          "K831010",
          "K230285",
          "K953935",
          "K831013",
          "K863880",
          "K935830",
          "K831021",
          "K160153",
          "K904188",
          "K014295",
          "K142898",
          "K991417",
          "K992859",
          "K100777",
          "K944089",
          "K834601",
          "K022746",
          "K895317",
          "K772307",
          "K831016",
          "K831017",
          "K961161",
          "K111188",
          "K760748",
          "K891578",
          "K192240",
          "K131126",
          "K943882",
          "K780716",
          "K012058",
          "K840843",
          "K800757",
          "K821483",
          "K012478",
          "K914560",
          "K810308",
          "K131988",
          "K850360",
          "K023567",
          "K852790",
          "K895181",
          "K080370",
          "K131703",
          "K970710",
          "K980991",
          "K831023",
          "K946206",
          "K963800",
          "K031560",
          "K203790",
          "K961657",
          "K913927",
          "K984384",
          "K853405",
          "K130144",
          "K141907",
          "K936203",
          "K832981",
          "K840300",
          "K860057",
          "K093280",
          "K200107",
          "K142220",
          "K922631",
          "K211559",
          "K831024",
          "K982277",
          "K252207",
          "K980130",
          "K882209",
          "K800224",
          "K792230",
          "K864445",
          "K812623",
          "K954711",
          "K954482",
          "K943570",
          "K063376",
          "K840468",
          "K915087",
          "K903965",
          "K061974",
          "K160412",
          "K935069",
          "K223608",
          "K002738",
          "K823750",
          "K800271",
          "K193246",
          "K123748",
          "K244014",
          "K120197",
          "K771822",
          "K781968",
          "K982928"
        ],
        "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1120",
        "device_class": "2",
        "registration_number": [
          "2050012",
          "1220972",
          "3004959793",
          "3013513377",
          "3004102403",
          "1219029",
          "3005643513",
          "3002807968",
          "9610633",
          "8030478",
          "9610126",
          "3007490412",
          "1217183",
          "1717966",
          "3023162659",
          "1220649",
          "1219913",
          "3037000637",
          "3003795116",
          "1036362",
          "3012104670",
          "1222035",
          "3002637618",
          "2245578",
          "2431530",
          "2432235",
          "1181121",
          "3007662974",
          "1000455123",
          "3015997711",
          "3012817228",
          "3006198300",
          "3014506106",
          "3003971136"
        ],
        "fei_number": [
          "2050012",
          "1220972",
          "3004959793",
          "3013513377",
          "3001576181",
          "3004102403",
          "1219029",
          "3005643513",
          "3002807968",
          "3002806693",
          "3007490412",
          "1217183",
          "1717966",
          "3002806559",
          "3023162659",
          "1220649",
          "1219913",
          "3037000637",
          "3003795116",
          "1036362",
          "3012104670",
          "1222035",
          "3002637618",
          "2245578",
          "2431530",
          "2432235",
          "1181121",
          "3007662974",
          "1000455123",
          "3015997711",
          "3012817228",
          "3006198300",
          "3014506106",
          "3003971136"
        ]
      }
    }
  ]
}