{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "105173",
      "product_res_number": "Z-0190-2012",
      "event_date_initiated": "2011-10-24",
      "event_date_posted": "2011-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-24",
      "res_event_number": "60366",
      "product_code": "KPO",
      "k_numbers": [
        "K041163"
      ],
      "product_description": "Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution.  4 oz plastic bottle.  Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.\n\nThe Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step",
      "code_info": "Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.",
      "firm_fei_number": "3013942511",
      "recalling_firm": "Isopure Corp",
      "address_1": "141 Citizens Blvd",
      "city": "Simpsonville",
      "state": "KY",
      "postal_code": "40067-6548",
      "additional_info_contact": "502-722-1000",
      "reason_for_recall": "The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).",
      "root_cause_description": "Employee error",
      "action": "Isopure sent a Product Recall Notice dated October 24, 2011, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately discontinue the use of any Step 2 chemical from the affected product, place any remaining chemical into the original box, seal it with tape, and segregate the product to prevent it from being placed back into stock.  The firm will pick up the product for return on a call tag.  Customers would receive replacement product for all affected cases of the Step 2 chemical the firm received.\n\nFor questions call 502-722-1000.",
      "product_quantity": "91cs/12/4 oz plastic bottles",
      "distribution_pattern": "Nationwide Distribution including the following states: AL, AZ, CA, FL, GA, IN, KS, LA, MA, MO, MS, NC, NH, NJ, NM, NV, OH, OR, PA, SC, TN, TX, and VA",
      "openfda": {
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          "K865078",
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          "K253462",
          "K823103",
          "K940601",
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        "registration_number": [
          "1835498",
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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"
      }
    }
  ]
}