{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194283",
      "product_res_number": "Z-1360-2022",
      "event_date_initiated": "2022-04-28",
      "event_date_created": "2022-07-11",
      "recall_status": "Open, Classified",
      "res_event_number": "90389",
      "product_code": "FIN",
      "k_numbers": [
        "K112427"
      ],
      "product_description": "Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)",
      "code_info": "UDI-DI: 00852456007085\n\nSerial numbers:\nSERIAL #\nIMP-113766\n5202061411P\n5201081501\nIMP-112232\nIMP-120373\nIMP-112737\nIMP-112606\nIMP-113620\nIMP-113580\nIMP-113085\nIMP-112842\nIMP-113812\nIMP-119050\nIMP-113811\nIMP-114975\nIMP-113810\nIMP-115147\nIMP-115148\nIMP-116155\nIMP-116060\nIMP-117241\nIMP-115146\nIMP-115145\nIMP-116662\nIMP-116996\nIMP-117110\nIMP-117278\nIMP-117739 \nIMP-117979\nIMP-118086\nIMP-118103\nIMP-118376\nIMP-118568\nIMP-118704\nIMP-118765\nIMP-119049\nIMP-119343\nIMP-118802\nIMP-119503\nIMP-119757\nIMP-119788\nIMP-120188\nIMP-120172\nIMP-120238\nIMP-120699\nIMP-120187\nIMP-114976\nIMP-119872\nIMP-120959\nIMP-120890\nIMP-121099\nIMP-121101\nIMP-121883\nIMP-117219\nIMP-121980\nIMP-122289\nIMP-122582\nIMP-122943\nIMP-115144\nIMP-123041\nIMP-124680\nIMP-825374\nIMP-124893\nIMP-825418\nIMP-124862\nIMP-124679\nIMP-825865\nIMP-826655\nIMP-826884\nIMP-826438\nIMP-826928\nIMP-826544\nIMP-827363\nIMP-827511\nIMP-827244\nIMP-830445\nIMP-826812\nIMP-827461\nIMP-119513\nIMP-827602\nIMP-828401\nIMP-119388\nIMP-121100\nIMP-829313\nIMP-830965 \nIMP-831004\nIMP-122583\nIMP-830617\nIMP-831413\nIMP-831594\nIMP-831197\nIMP-831894\nIMP-831929\nIMP-832283\nIMP-832381 \nIMP-832706\nIMP-113809\nIMP-832925 \nIMP-833088\nIMP-833120\nIMP-833428\nIMP-833769\nIMP-833916\nIMP-833942\nIMP-830374\nIMP-120755\nIMP-834278 \nIMP-833473\nIMP-834575\nIMP-834798\nIMP-123026\nIMP-835190\nIMP-835138\nIMP-835454\nIMP-835973\nIMP-838703\nIMP-839160\nIMP-840230\nIMP-840914\nIMP-831334\nIMP-120670",
      "firm_fei_number": "3013942511",
      "recalling_firm": "Isopure Corp",
      "address_1": "11851 Plantside Dr",
      "city": "Louisville",
      "state": "KY",
      "postal_code": "40299-6328",
      "additional_info_contact": "Isopure Customer/Technical Support\n502-267-7873",
      "reason_for_recall": "Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.",
      "root_cause_description": "Other",
      "action": "Firm began to call customers on April 28, 2022, to determine if the IsoMix Pro is still in use at each location. The firm will also be sending an email out to all clinics along with an updated Safety Notice. Once information is gathered, service technicians will visit each clinic to assess the devices.\n\nCustomers will be provided with a video link as part of an inspection packet on proper use of a torque screwdriver. Customers should follow the provided guidance documents. Customers should always replace any depleted or blown fuses with the correct size. Customers are also instructed to follow the recommended preventive maintennace schedule for the device.",
      "product_quantity": "119",
      "distribution_pattern": "Domestic distribution to AL\nAZ\nCO\nDE\nFL\nGA\nIN\nKS\nKY\nLA\nMA\nMD\nME\nMN\nMO\nNC\nNY\nOK\nPA\nTX\nUT\nVA\nWV\n\nNo foreign distribution.",
      "openfda": {
        "k_number": [
          "K970674",
          "K873166",
          "K992793",
          "K112427",
          "K140984",
          "K093641",
          "K060333",
          "K993058",
          "K141213",
          "K003560",
          "K883408",
          "K030366",
          "K961416",
          "K993272",
          "K031502",
          "K051031",
          "K023011",
          "K033118"
        ],
        "device_name": "Tank, Holding, Dialysis",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "3019131",
          "3003768032",
          "1530185",
          "3005021818",
          "1055109"
        ],
        "fei_number": [
          "1000112932",
          "1000515504",
          "3005021818",
          "3006475063",
          "3013942511"
        ]
      }
    }
  ]
}