{
  "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": "94221",
      "product_res_number": "Z-0104-2011",
      "event_date_initiated": "2010-09-03",
      "event_date_posted": "2010-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-02-16",
      "res_event_number": "56675",
      "product_code": "FKX",
      "k_numbers": [
        "K043363"
      ],
      "product_description": "LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.",
      "code_info": "Lot Number    Expiration Date 09CR08086   03/31/2012 09DR08038   04/30/2012 09JR08092    07/31/2012 09JR08093    07/31/2012 09KR08061   08/31/2012",
      "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": "Kathleen Storro\n800-662-1237",
      "reason_for_recall": "Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.",
      "product_quantity": "1524 units",
      "distribution_pattern": "Nationwide Distribution: Throughout USA.",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
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}