{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220066",
      "product_res_number": "Z-2321-2026",
      "event_date_initiated": "2026-05-12",
      "event_date_posted": "2026-06-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98877",
      "product_code": "KPO",
      "k_numbers": [
        "K233950",
        "K243786"
      ],
      "product_description": "Bicarby\" Dialysate;\nModel Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;",
      "code_info": "Model Number: RFP-400-G; UDI-DI: 00840861102839;\n2. Model Number: RFP-401-G; UDI-DI: 00840861102853;\n3. Model Number: RFP-402-G; UDI-DI: 00840861102822;\n4. Model Number: RFP-404-G; UDI-DI: 00840861102914;\n5. Model Number: RFP-407-G; UDI-DI: 00840861102846:\n6. Model Number: RFP-456-G; UDI-DI: 00840861102945;\n\nAll lots produced from January 13, 2025, through lot 26AG02019 on\nJanuary 13, 2026",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Fresenius Customer Service Team\n800-323-5188",
      "reason_for_recall": "Given the increased number of leaks reported by\nusers, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard\nassociated with fluid on the floor.",
      "root_cause_description": "Process design",
      "action": "On 5/12/2026 an IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers to inform them that manipulation of the luer-lock location during treatment preparation may result in fluid spillage onto the user and floor. This occurs prior to treatment and renders the product unusable. Direct contact with the fluid does not present any risk to the user as frangible manipulation only occurs after the peal seam has been broken and the two fluid compartments have been mixed. The potential risk associated with the affected Bicarby Dialysate product is a slip and fall hazard due to the presence of fluid on the floor.",
      "product_quantity": "1,756,108 units",
      "distribution_pattern": "US Nationwide distribution in the states of NY, TN and TX.",
      "openfda": {
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
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        ],
        "registration_number": [
          "1056186",
          "3005578748",
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