{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63381",
      "recalling_firm": "Sorin Group USA, Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "N/A",
      "postal_code": "80004",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.",
      "recall_number": "Z-0166-2013",
      "product_description": "SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.    The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.",
      "product_quantity": "12 units (3 units USA and 9 units OUS)",
      "reason_for_recall": "Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel .  An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display.  The flow and pressure display information may also be incorrect after the malfunction.",
      "recall_initiation_date": "20120920",
      "center_classification_date": "20121029",
      "termination_date": "20130128",
      "report_date": "20121107",
      "code_info": "Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.",
      "more_code_info": ""
    }
  ]
}