{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waltham",
      "address_1": "920 Winter St",
      "reason_for_recall": "The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.",
      "address_2": "",
      "product_quantity": "133,751 in total  (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)",
      "code_info": "Serial Numbers:  0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016",
      "center_classification_date": "20150429",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.",
      "state": "MA",
      "product_description": "2008 Series Hemodialysis Machines: 2008T with the following product code and description:  190395 2008K at Home System - 1st Gen. -¿ Canada;   190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM;   190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP    The Fresenius 2008K is indicated for acute and chronic dialysis therapy.",
      "report_date": "20150506",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-1550-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70574",
      "termination_date": "20210518",
      "more_code_info": "",
      "recall_initiation_date": "20150220",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}