{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "195663",
      "product_res_number": "Z-1769-2022",
      "event_date_initiated": "2022-06-21",
      "event_date_posted": "2022-09-19",
      "recall_status": "Open, Classified",
      "res_event_number": "90757",
      "product_code": "FIP",
      "k_numbers": [
        "K143617"
      ],
      "product_description": "AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. \n\nFresenius Part Number: 24-10VA-1\nVivonic Part Number: G02000970-US",
      "code_info": "UDI:\n(01)4251285200234(11)210628(21)1CHS5379\n(01)4251285200234(11)160927(21)6CHS1270\n(01)4251285200234(11)161109(21)6CHS1394\n(01)4251285200234(11)161109(21)6CHS1435\n(01)4251285200234(11)170131(21)7CHS1569\n(01)4251285200234(11)170201(21)7CHS1583\n(01)4251285200234(11)170213(21)7CHS1619\n(01)4251285200234(11)170314(21)7CHS1641\n(01)4251285200234(11)170519(21)7CHS1790\n(01)4251285200234(11)170807(21)7CHS1953\n(01)4251285200234(11)180326(21)8CHS2197\n(01)4251285200234(11)181010(21)8CHS2608\n(01)4251285200234(11)181102(21)8CHS2633\n(01)4251285200234(11)181107(21)8CHS2644\n\nSerial Numbers:\n1CHS5379\n6CHS1192\n6CHS1194\n6CHS1195\n6CHS1196\n6CHS1197\n6CHS1198\n6CHS1199\n6CHS1200\n6CHS1201\n6CHS1233\n6CHS1270\n6CHS1394\n6CHS1435\n7CHS1569\n7CHS1583\n7CHS1619\n7CHS1641\n7CHS1790\n7CHS1953\n8CHS2197\n8CHS2608\n8CHS2633\n8CHS2644",
      "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": "SAMe\n781-6999580",
      "reason_for_recall": "Internal ethemet cables are missing one or both ferrite cores therefore  the electromagnetic compatibility of the device is not ensured",
      "root_cause_description": "Under Investigation by firm",
      "action": "Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) issued Urgent Medical Deice Correction letter (FA-2022-20-C) on 06/21/22 via First Class Mail. Letter states reason for recall, health risk and action to take:\nA Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service\nSpecialist will be contacting you to schedule a correction of your portable Water Treatment\nsystem. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service\nSpecialist may perform this service. If choosing to correct via your own Certified AquaC UNO H\nSystem Technician, you will need to contact FMCRTG prior to performing the correction.\nFMCRTG will provide the necessary instruction via a Change Notification.\nFor questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.",
      "product_quantity": "24 units",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.",
      "openfda": {
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        "registration_number": [
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        ],
        "device_name": "Subsystem, Water Purification",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5665",
        "device_class": "2"
      }
    }
  ]
}