{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "141212",
      "product_res_number": "Z-0294-2016",
      "event_date_initiated": "2015-10-23",
      "event_date_created": "2015-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-03-02",
      "res_event_number": "72484",
      "product_code": "KPO",
      "k_numbers": [
        "K911459"
      ],
      "product_description": "Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101.\r\n\r\nFor Use in the Preparation of acid concentrate for hemodialysis.",
      "code_info": "All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "SAME\n781-699-9000",
      "reason_for_recall": "Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.",
      "root_cause_description": "Device Design",
      "action": "Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15.  The letter identified the affected device and the reason for the recall.  It also contained instructions (on how to perform the required wiring modification) along with a Reply Form.  Customers are to return the form after completing the modification.  Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.",
      "product_quantity": "918 units",
      "distribution_pattern": "Nationwide Distribution.",
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        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}