{
  "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": "94222",
      "product_res_number": "Z-0105-2011",
      "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"
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      "product_description": "LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.",
      "code_info": "Lot Number    Expiration Date 09ER08101     05/31/2012 09HR08002     06/30/2012 09HR08003      06/30/2012 09JR08057       07/31/2012 09JR08058       07/31/2012 09JR08059       07/31/2012 09KR08002      08/31/2012 09KR08003      08/31/2012 09KR08004      08/31/2012 09KR08005      08/31/2012 09LR08004      09/30/2012 09LR08005      09/30/2012 09LR08006      09/30/2012 09LR08007      09/30/2012 09LR08008       09/30/2012 09LR08010       09/30/2012 09LR08105       09/30/2012",
      "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": "5799 units",
      "distribution_pattern": "Nationwide Distribution: Throughout USA.",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
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