{
  "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": "31065",
      "product_res_number": "Z-0352-04",
      "event_date_initiated": "2003-12-30",
      "event_date_posted": "2004-01-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-02-03",
      "res_event_number": "28027",
      "product_code": "FJI",
      "k_numbers": [
        "K002512"
      ],
      "product_description": "Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8",
      "code_info": "Lot numbers:  20310140, 20910540, and 20910541.  (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003.  Expiry year dates are 04 or 2004 to 06 or 2006.  An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)",
      "firm_fei_number": "3001632632",
      "recalling_firm": "Toray Marketing & Sales (America), Inc",
      "address_1": "140 Cypress Station Dr Ste 210 140 Cypress Station Dr",
      "address_2": "Ste 210",
      "city": "Houston",
      "state": "TX",
      "postal_code": "77090-1627",
      "reason_for_recall": "Potential loose header (end cap) on hollow fiber dialyzers.",
      "root_cause_description": "Other",
      "action": "Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004.  Firm is also notifying all consignees by  letter with a response form, sent by certified mail.",
      "product_quantity": "384 units",
      "distribution_pattern": "California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.",
      "openfda": {
        "k_number": [
          "K812353",
          "K980658",
          "K801825",
          "K770734",
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          "K892523",
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          "K800549",
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          "K850655",
          "K791321",
          "K851380",
          "K862693",
          "K891477",
          "K871236",
          "K883748",
          "K991512",
          "K770867",
          "K950454",
          "K800270",
          "K893677",
          "K945623",
          "K861916",
          "K853591",
          "K122952",
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          "K874549",
          "K903567",
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          "K991908",
          "K802441",
          "K850865",
          "K935471",
          "K870725",
          "K905228",
          "K854280",
          "K962309",
          "K992594",
          "K902481",
          "K952343",
          "K800336",
          "K790696",
          "K820524",
          "K802114",
          "K882215",
          "K881811",
          "K802466",
          "K883644",
          "K926567",
          "K874728",
          "K926372",
          "K011148",
          "K821690",
          "K801559",
          "K963933",
          "K802092",
          "K882680",
          "K883534",
          "K926005",
          "K010366",
          "K800221",
          "K800704",
          "K801178",
          "K904566",
          "K790308",
          "K792419",
          "K854575",
          "K771694",
          "K821587",
          "K950602",
          "K870169",
          "K802893",
          "K861537",
          "K782151",
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          "K883589",
          "K874872",
          "K973291",
          "K970708",
          "K781058",
          "K944436",
          "K871471",
          "K882339",
          "K791322",
          "K880083",
          "K945746",
          "K850654",
          "K772423",
          "K820743",
          "K940910",
          "K855212",
          "K941708",
          "K790067",
          "K190459",
          "K801370",
          "K892374",
          "K772290",
          "K890111",
          "K892375",
          "K930503",
          "K781142",
          "K961026",
          "K990159",
          "K043342",
          "K791320",
          "K861536",
          "K905779",
          "K945622",
          "K802613",
          "K801192",
          "K801826",
          "K992565",
          "K882213",
          "K802894",
          "K971710"
        ],
        "device_name": "Dialyzer, Capillary, Hollow Fiber",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "1932668",
          "3038195011",
          "1225714",
          "8030639",
          "2028411",
          "9611369",
          "1721676",
          "1713747"
        ],
        "fei_number": [
          "3038195011",
          "6898",
          "1000138417",
          "3001451489",
          "3002807035",
          "1721676",
          "1000125241",
          "1713747"
        ]
      }
    }
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}