{
  "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": [
    {
      "status": "Terminated",
      "city": "Lawrence",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68354",
      "recalling_firm": "NxStage Medical, Inc.",
      "address_1": "350 Merrimack Street",
      "address_2": "N/A",
      "postal_code": "01843-1748",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.",
      "recall_number": "Z-1855-2014",
      "product_description": "NxStage Dialysate Sack (SAK) with Concentrate  for Use with PureFlow SL  REF: SAK-302  Lactate , 40, Potassium 1, Sodium\t140, Calcium 3,  Magnesium 1, Chloride 105, Glucose (mg/dL)\t100,   Batch Size (liters): 60\t    The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.",
      "product_quantity": "19423 cases",
      "reason_for_recall": "SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",
      "recall_initiation_date": "20140514",
      "center_classification_date": "20140624",
      "termination_date": "20170313",
      "report_date": "20140702",
      "code_info": "Lot codes:  40179127   40179107   40179109   40179105   40179093   40179034  31279120   31279118   3057921   3057920   3057915   3057914   3057906   3057905  3047924  3047923"
    }
  ]
}