{
  "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": "159851",
      "product_res_number": "Z-0401-2018",
      "event_date_initiated": "2017-10-30",
      "event_date_created": "2018-01-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-01-26",
      "res_event_number": "78594",
      "product_code": "DWA",
      "k_numbers": [
        "K112225"
      ],
      "product_description": "CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel.  It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.",
      "code_info": "Model No. 60-00-60.  Drive Unit: Ref #60-01-04, UDI 04033817900948.  Emergency System: Ref #60-01-35, UDI 04033817900955.  Pump Control Panel: Ref #60-02-60, UDI 04033817901006.",
      "firm_fei_number": "3002808267",
      "recalling_firm": "Sorin Group Deutschland GmbH",
      "address_1": "Lindberghstr. 25 25 lindberghstr.",
      "city": "Munich",
      "country": "Germany",
      "additional_info_contact": "800-9864702",
      "reason_for_recall": "Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.",
      "root_cause_description": "Device Design",
      "action": "Consignees were notified of the recall via USPS trackable mail, beginning on 10/30/2017.  The letter informed customers Instructions included to continue following the Instructions for use, including use of an arterial filter on the arterial line, and that a LivaNova representative will contact them to schedule an upgrade to their device.",
      "product_quantity": "1,318 units",
      "distribution_pattern": "Distributed domestically to \n\nDistributed internationally to Algeria, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Jordan, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Morocco, Norway, Palestinian Territory, Panama, Peru, Poland, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, The Netherlands, Tunisia, United Kingdom, Vietnam",
      "openfda": {
        "k_number": [
          "K011838",
          "K102129",
          "K901584",
          "K081221",
          "K950739",
          "K941921",
          "K924205",
          "K232788",
          "K230698",
          "K112225",
          "K051303",
          "K780952",
          "K091008",
          "K042374",
          "K200306",
          "K936091",
          "K093832",
          "K853126",
          "K914754",
          "K061369",
          "K221491",
          "K854133",
          "K926357",
          "K032213",
          "K131964",
          "K191557",
          "K924206",
          "K053630",
          "K083340",
          "K103468",
          "K192838",
          "K070286",
          "K971421",
          "K090004",
          "K131179",
          "K080824",
          "K842503"
        ],
        "registration_number": [
          "3044156918",
          "3004593495",
          "3019807891",
          "3014990448",
          "3021562887",
          "3003306248",
          "9611109",
          "1928237",
          "3015431638",
          "3010163695",
          "3012119238",
          "1828100",
          "2916596",
          "2011171",
          "1218444",
          "3008792657",
          "3010009632",
          "2029275",
          "1220648",
          "2184009",
          "9617601"
        ],
        "fei_number": [
          "3044156918",
          "3004593495",
          "3019807891",
          "3002534070",
          "3014990448",
          "3021562887",
          "3003306248",
          "1000116158",
          "1928237",
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          "2916596",
          "3002808267",
          "2011171",
          "1218444",
          "3008792657",
          "1000306431",
          "3010009632",
          "1220648"
        ],
        "device_name": "Control, Pump Speed, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4380",
        "device_class": "2"
      }
    }
  ]
}