{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121293",
      "product_res_number": "Z-0185-2014",
      "event_date_initiated": "2013-08-29",
      "event_date_posted": "2013-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-02-11",
      "res_event_number": "65739",
      "product_code": "ONW",
      "k_numbers": [
        "K070049"
      ],
      "product_description": "Combiset Blood Line with BVM for Hemodialysis use\r\nCatalog Number: 03-2965-9.\r\n\r\nIntended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.",
      "code_info": "All lot codes",
      "firm_fei_number": "3001451489",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1521",
      "additional_info_contact": "800-662-1237",
      "reason_for_recall": "Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may  disconnect and lead to blood loss",
      "root_cause_description": "Labeling design",
      "action": "Fresenius issued a Field Notification Letter dated 8/29/13  to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure.\r\nThis field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested  to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice.\r\nIf you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.",
      "product_quantity": "24,202 cases",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the country of Canada.",
      "openfda": {
        "k_number": [
          "K124035",
          "K121421",
          "K242269",
          "K070049"
        ],
        "registration_number": [
          "3015335038",
          "9680579",
          "1225714",
          "8030665",
          "3004111573",
          "1650907"
        ],
        "fei_number": [
          "3015335038",
          "1000203464",
          "3002807744",
          "3002681132",
          "3004111573",
          "3001451489"
        ],
        "device_name": "Hemodialysis System For Home Use",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5860",
        "device_class": "2"
      }
    }
  ]
}