{
  "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,
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  "results": [
    {
      "cfres_id": "122079",
      "product_res_number": "Z-0148-2014",
      "event_date_initiated": "2013-10-14",
      "event_date_posted": "2013-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-05-18",
      "res_event_number": "66339",
      "product_code": "FKX",
      "k_numbers": [
        "K043363"
      ],
      "product_description": "Fresenius Liberty Cycler\nPart Number: RTLR180111\n\nProduct Usage:\nThe Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.",
      "code_info": "All serial numbers",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "800-662-1237",
      "reason_for_recall": "Fluid leaking may be observed inside the pump compartment of the Liberty Cycler  and  may result in dialysate becoming contaminated, potentially causing peritonitis",
      "root_cause_description": "Device Design",
      "action": "Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.",
      "product_quantity": "16,600",
      "distribution_pattern": "USA Nationwide Distribution",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}