{
  "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": "109800",
      "product_res_number": "Z-0051-2013",
      "event_date_initiated": "2012-09-24",
      "event_date_posted": "2012-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-11-13",
      "res_event_number": "62059",
      "product_code": "KFM",
      "k_numbers": [
        "K882758"
      ],
      "product_description": "Sarns Centrifugal System Control module, 100/115V\n\nThe Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.",
      "code_info": "Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "734-741-6173",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of\npower to the control module and subsequently the drive motor for the Sarns\ncentrifugal system during cardiopulmonary bypass.",
      "root_cause_description": "Component design/selection",
      "action": "TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees.  An Addendum was sent on September 25, 2012.  All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall.\nFor questions customers should call 1-800-521-2818.\nFor questions regarding this recall call 734-741-6173.",
      "product_quantity": "847 units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.",
      "openfda": {
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          "K031300",
          "K233091",
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        "registration_number": [
          "2029275",
          "1828100",
          "3030125051",
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          "3006003617",
          "3003306248"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}