{
  "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": "220088",
      "product_res_number": "Z-2401-2026",
      "event_date_initiated": "2026-05-07",
      "event_date_posted": "2026-06-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98892",
      "product_code": "KPO",
      "k_numbers": [
        "K243786"
      ],
      "product_description": "Bicarby Dialysate; Model number: RFP-400-G;",
      "code_info": "Model number: RFP-400-G;\nUDI-DI: 00840861102839;\nLot codes: 25SG06026, 25SG06027;",
      "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": "There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.",
      "root_cause_description": "Process control",
      "action": "On 5/7/2026 an URGENT MEDICAL DEVICE RECALL letters were sent to customers.\nAt this time, FMCRTG is providing this recall notice to alert you of the potential risks associated with the labeling error, and to ask that you identify, segregate, and discontinue use of affected lots, 25SG06026 and 25SG06027, of RFP-400-G Bicarby Dialysate. FMCRTG is requiring the return of the affected Bicarby Dialysate lots. FMCRTG will replace all remaining stock of affected product lots.\nFor product technical questions or concerns, please contact Technical Support at 1-800-323-2732 or Customer Support at 1-800-323-5188 between 8:30AM   4:30PM Eastern Daylight Time. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.",
      "product_quantity": "4752",
      "distribution_pattern": "Domestic: 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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