{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "41081",
      "product_res_number": "Z-0140-06",
      "event_date_initiated": "2005-07-26",
      "event_date_posted": "2005-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-05-02",
      "res_event_number": "32923",
      "product_code": "KFM",
      "k_numbers": [
        "K962981"
      ],
      "product_description": "Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump\nThe centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A.  The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows:\nConvenience Kit Identifier Code/Kit Lot Numbers:\n65077\t        FA17\n62266-01\t        EP13\n62266-01\t        FA31\n63819-01           FC07\n64034\t       FA03\n64033\t       FD07\n70131\t       FA03\n70131\t      FA10\n63607\t      FA31\n63607\t      FD07\n64091\t      FC07\n64338\t      EP13\n64338\t      FC07\n70964\t     EP20\n70964\t     FD07\n70014-02\t   EP13\n70014-02\t   FA03\n70014-02\t   FC07\n70014-02\t   FC07T\n70014-02\t   FD07\n70226-01\t   FD07\n64987\t  FA24\n64987\t  FD14\n62933-01\t  FD14\n62984-01\t  FA24\n63004-01\t  FA03\n63004-01\t  FA24\n63361-01\t  EP27\n63118\t  EP13\n63118-01     FA24\n63118-01\t FC28\n63118-01\t FD14",
      "code_info": "Convenience Kit Identifier Code/Kit Lot Numbers: 65077\t        FA17 62266-01\t        EP13 62266-01\t        FA31 63819-01           FC07 64034\t       FA03 64033\t       FD07 70131\t       FA03 70131\t      FA10 63607\t      FA31 63607\t      FD07 64091\t      FC07 64338\t      EP13 64338\t      FC07 70964\t     EP20 70964\t     FD07 70014-02\t   EP13 70014-02\t   FA03 70014-02\t   FC07 70014-02\t   FC07T 70014-02\t   FD07 70226-01\t   FD07 64987\t  FA24 64987\t  FD14 62933-01\t  FD14 62984-01\t  FA24 63004-01\t  FA03 63004-01\t  FA24 63361-01\t  EP27 63118\t  EP13 63118-01     FA24 63118-01\t FC28 63118-01\t FD14",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "Brian Dawson\n734-741-6066",
      "reason_for_recall": "Small cracks in the blood chamber may allow air to enter the rotor of the device",
      "root_cause_description": "Other",
      "action": "Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product.",
      "product_quantity": "893 kits",
      "distribution_pattern": "AZ, CA, KY, IL, LA,  MD, WA , WI",
      "openfda": {
        "k_number": [
          "K962981",
          "K011835",
          "K973011",
          "K061072",
          "K082321",
          "K111657",
          "K090515",
          "K073631",
          "K921550",
          "K913176",
          "K030462",
          "K013393",
          "K854975",
          "K110493",
          "K250326",
          "K110845",
          "K232132",
          "K030154",
          "K770937",
          "K032040",
          "K991864",
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          "K842007",
          "K191077",
          "K050109",
          "K103357",
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          "K063723",
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          "K111658",
          "K894255",
          "K012209",
          "K900601",
          "K992592",
          "K852698",
          "K080470",
          "K020998",
          "K111384",
          "K112229",
          "K915547",
          "K882129",
          "K882758",
          "K170029",
          "K902404",
          "K884659",
          "K100631",
          "K051209",
          "K200091",
          "K080774",
          "K201068",
          "K780953",
          "K192850",
          "K020529",
          "K902198",
          "K915363",
          "K943861",
          "K201320",
          "K193663",
          "K183623",
          "K023132",
          "K133265",
          "K933014",
          "K983272",
          "K050890",
          "K132712",
          "K111972",
          "K020271",
          "K903925",
          "K090051",
          "K972740",
          "K852807",
          "K251762",
          "K851613",
          "K083111",
          "K033270",
          "K991783",
          "K912604",
          "K220842",
          "K031300",
          "K233091",
          "K083794",
          "K190650",
          "K202169",
          "K851855"
        ],
        "registration_number": [
          "2029275",
          "1828100",
          "3030125051",
          "3009507273",
          "3010163695",
          "1218444",
          "9681834",
          "3044156918",
          "2011171",
          "1124841",
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          "3005941719",
          "2916596",
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          "3008792657",
          "3014990448",
          "1319639",
          "2528981",
          "8010026",
          "1422634",
          "3019807891",
          "3002807090",
          "1123137",
          "3003661577",
          "3016746283",
          "1928237",
          "3006073153",
          "1220648",
          "8010762",
          "3003306248",
          "9680841",
          "9617601"
        ],
        "fei_number": [
          "1828100",
          "3002534070",
          "3030125051",
          "1000138054",
          "3009507273",
          "3010163695",
          "3005426550",
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          "3044156918",
          "2011171",
          "1000123180",
          "1000514656",
          "3009380063",
          "2916596",
          "3012119238",
          "3011554160",
          "1000306431",
          "3007427881",
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          "3006849754",
          "3002807111",
          "3008792657",
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          "1928237",
          "1000116158",
          "3006073153",
          "1220648",
          "3000204839",
          "3006003617",
          "3003306248"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}