{
  "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": "2026-04-08",
    "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": "79185",
      "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 to the countries of :  United Kingdom & Spain",
      "recall_number": "Z-0811-2018",
      "product_description": "NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070    Hemodialysis systems and accessories",
      "product_quantity": "16,039 cases/2 units",
      "reason_for_recall": "May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare  product.",
      "recall_initiation_date": "20180129",
      "center_classification_date": "20180301",
      "termination_date": "20200403",
      "report_date": "20180307",
      "code_info": "SAK-301- Lot # 70879245, Exp Date 7/11/2019  SAK-302- Lot # 71079056, Exp Date 7/30/2019  SAK-303- Lot #'s 70879181 & 70879224,   SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019  SAK-306- Lot # 70979110, Exp Date 7/24/2019  SAK-307- Lot #'s  70879187 & 71079144, Exp Date 8/27/2019  SAK-402- Lot # 70879235, Exp Date 7/11/2019  SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019  SAK-406- Lot #'s 70979253, Exp Date 7/29/2019  SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019"
    }
  ]
}