{
  "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": "2026-09-17",
    "results": {
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      "cfres_id": "214528",
      "product_res_number": "Z-2193-2025",
      "event_date_initiated": "2025-06-27",
      "event_date_posted": "2025-07-29",
      "recall_status": "Open, Classified",
      "res_event_number": "97097",
      "product_code": "KRI",
      "product_description": "Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.",
      "code_info": "Model No. 701033599; UDI: 4037691257860.",
      "firm_fei_number": "3009507273",
      "recalling_firm": "Maquet Cardiopulmonary Gmbh",
      "address_1": "Kehler Str. 31 31 kehler str.",
      "city": "Rastatt",
      "country": "Germany",
      "reason_for_recall": "Device does not comply with the labeling requirements of international standard IEC 60601-1.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT MEDICAL DEVICE CORRECTION NOTICE dated June 2025 was mailed to consignees. The notification informs consignees that Getinge will be sending a field service technician to visit and verify if a safety sign is present on affected devices. Consignees are asked to share the recall notification with users of affected devices or to facilities to which product was further distributed for their awareness. Consignees are to complete and return the provided response form to recallresponses.qrc@getinge.com. Consignees with any questions are to direct them to Technical Support at 1-877-943-8872 (options 4, 2, 1) or by email at techsupport.us@getinge.com.",
      "product_quantity": "7,754 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.",
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        "device_name": "Accessory Equipment, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4200",
        "device_class": "1"
      }
    }
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}