{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85898",
      "product_res_number": "Z-0545-2010",
      "event_date_initiated": "2009-07-06",
      "event_date_posted": "2009-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-11-09",
      "res_event_number": "53577",
      "product_code": "KFM",
      "k_numbers": [
        "K915363"
      ],
      "product_description": "Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units.\n\nIndicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures  lasting up to 6-hours.",
      "code_info": "Product Number: 164275, Serial Numbers: KN10, KN26, KP08, LA05, LA12, LA19, LA22, LA26, LC12, LC16, LD16, LD23, LE01, LE15, LE22, LE29 and LF07.",
      "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": "Garry Courtney\n800-283-7866 Ext. 7420",
      "reason_for_recall": "The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.",
      "root_cause_description": "Device Design",
      "action": "Terumo Cardiovascular Systems Corporation notified consignees of an \"Urgent Medical Device Correction\" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form.\n\nFor further information, contact Terumo CVS Customer Service at 1-800-521-2818.",
      "product_quantity": "13,753 units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K111658",
          "K110493",
          "K250326",
          "K111972",
          "K110845",
          "K023132",
          "K973011",
          "K132712",
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          "K852807",
          "K201068",
          "K900601",
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          "K912604",
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        "registration_number": [
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          "2011171",
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          "3009380063",
          "2528981",
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        ],
        "fei_number": [
          "1000116158",
          "1000138054",
          "2011171",
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          "3009380063",
          "2528981",
          "3016746283",
          "3002807111",
          "3044156918"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      }
    }
  ]
}