{
  "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-1854-2014",
      "product_description": "NxStage Dialysate Sack (SAK) with Concentrate  for Use with PureFlow SL  REF: SAK-301  Lactate 45, Potassium \t1, Sodium 140, Calcium 3, Magnesium 1,  Chloride 100, Glucose (mg/dL) 100  Batch Size (liters)\t60    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": "13474 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:  40279015  40179163  40179162  31279127  3067903  3057931  3057930  3047933  3047928"
    }
  ]
}