{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "183952",
      "product_res_number": "Z-0439-2021",
      "event_date_initiated": "2020-09-12",
      "event_date_created": "2020-11-07",
      "recall_status": "Completed",
      "res_event_number": "86537",
      "product_code": "FKX",
      "k_numbers": [
        "K171652"
      ],
      "product_description": "Liberty Select Cycler\nSoftware Version 2.9.0\nModel Number 180343 and RTLR180343",
      "code_info": "All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Fresenius Medical Care Technical Service\n800-227-2572",
      "reason_for_recall": "The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.",
      "root_cause_description": "Device Design",
      "action": "On September 16, 2020, Urgent Medical Device Correction notices and response forms were issued to home therapy nurse managers and patients.  \n\nPatients using a Liberty Select cycler with software version 2.9.0 are instructed to disable the Flow Alert option. Patients will no longer receive on an-screen Flow Alert message or an audible Flow Alert series of beeps. Instructions for disabling the Flow Alert alarm are included in the notification letter. Patients should continue to use their Liberty Select Cycler for treatment with the Flow Alert option set to \"No\". Fresenius Medical Care LLC is not requesting the return of the Liberty Select cyclers software version 2.9.0. Replacing the Liberty Select cycler will not resolve this issue. Please complete and return the enclosed Reply Form, indicating receipt and understanding of the communication and actions to take.\n\nFor additional information, please call 1-855-616-2309 Monday - Friday 8:30 am-5 pm, EST or submit an online request any time at www.fmcna-medinfo.com.",
      "product_quantity": "9,907 devices",
      "distribution_pattern": "Distributed nationwide throughout the U.S and Puerto Rico.\n9,907 devices currently in the field.\n361 devices have been deactivated.\n4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
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}