{
  "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": "102865",
      "product_res_number": "Z-0303-2012",
      "event_date_initiated": "2011-10-21",
      "event_date_posted": "2011-11-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-17",
      "res_event_number": "59479",
      "product_code": "DWB",
      "k_numbers": [
        "K915183"
      ],
      "product_description": "Battery Module for Sarns Modular Perfusion System 8000 \n\nProduct Usage:  The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.",
      "code_info": "Catalog Number 16422 Serial Number 1901",
      "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 is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000  was shipped to a single customer.  The affected board mislabeled two connection between the board and the transformer.",
      "root_cause_description": "Employee error",
      "action": "Terumo conducted a Correction/Removal - Customer Communicated Script  on November 7, 2011 to the affected customer.  The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module.  A replacement date was set for November 7, 2011.  For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.",
      "product_quantity": "10 units",
      "distribution_pattern": "Nationwide Distribution (USA) including the state of San Antonio, TX",
      "openfda": {
        "k_number": [
          "K861714",
          "K862116",
          "K874771",
          "K112587",
          "K820729",
          "K131618",
          "K162843",
          "K890904",
          "K780942",
          "K955038",
          "K953904",
          "K802714",
          "K972321",
          "K831458",
          "K881780",
          "K971520",
          "K822071",
          "K960974",
          "K973237",
          "K813035",
          "K953901"
        ],
        "registration_number": [
          "3001589655",
          "3042990265",
          "1828100"
        ],
        "fei_number": [
          "3001589655",
          "3042990265",
          "1828100"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4370",
        "device_class": "2"
      }
    }
  ]
}