{
  "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-1857-2014",
      "product_description": "NxStage Dialysate Sack (SAK) with Concentrate  for Use with PureFlow SL  REF: SAK-304  Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,   Chloride 101, Glucose (mg/dL) 100  Batch Size (liters) 60    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": "16,625 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 code:  40179091  40179069   40179068  40179029   40179019   31279094   3067901   3057932   3057919   3057918   3057909   3057908"
    }
  ]
}