{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196258",
      "product_res_number": "Z-0181-2023",
      "event_date_initiated": "2022-10-04",
      "event_date_posted": "2022-11-04",
      "recall_status": "Open, Classified",
      "res_event_number": "90947",
      "product_code": "KPO",
      "k_numbers": [
        "K070177"
      ],
      "product_description": "NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case.  For dialysis.",
      "code_info": "UDI-DI: 00840861101610\nLots:\n20LTAC076\n20PTAC094\n21ATAC046\n21BTAC082\n21CTAC029\n21KTAC072\n21PTAC023\n21STAC094\n22DTAC036",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "Fresenius Medical Care Technical Service\n800-227-2572",
      "reason_for_recall": "The \"Nominal Chemical Composition\" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.",
      "root_cause_description": "Error in labeling",
      "action": "On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product.\n\nPlease contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.",
      "product_quantity": "17700",
      "distribution_pattern": "Domestic distribution to AL\nAZ\nCA\nDC\nFL\nGA\nHI\nIL\nIN\nMD\nMI\nMO\nMS\nNE\nNJ\nNY\nOH\nPA\nSD\nTX\nVA\n\nNo foreign distribution.",
      "openfda": {
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          "K012328",
          "K834538",
          "K854206",
          "K990010",
          "K910319",
          "K171750",
          "K864265",
          "K781967",
          "K090002"
        ],
        "registration_number": [
          "3013764800",
          "8030639",
          "2029275",
          "3007137482",
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        "fei_number": [
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        ],
        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}