{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waltham",
      "address_1": "920 Winter St",
      "reason_for_recall": "2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup",
      "address_2": "",
      "product_quantity": "111,504 units US and 3,638 Canada and Mexico-",
      "code_info": "All serial numbers",
      "center_classification_date": "20140106",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.",
      "state": "MA",
      "product_description": "Fresenius 2008 Series Hemodialysis Machines:  Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T    The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.",
      "report_date": "20140115",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-0629-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66622",
      "termination_date": "20190326",
      "more_code_info": "",
      "recall_initiation_date": "20131112",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}