{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Lawrence",
      "address_1": "350 Merrimack St",
      "reason_for_recall": "There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with  for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.",
      "address_2": "",
      "product_quantity": "1803 units",
      "code_info": "Product 1) UDI # - M535NX100010  Product 2) UDI # - M535NX1000160 and M535NX100016A0  Product 3) UDI # - M535NX100030 and M535NX10003A0  Product 4) UDI # - M535NX1000100 and M535NX100010A0     Lot Numbers:   60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002",
      "center_classification_date": "20191218",
      "distribution_pattern": "AL, AZ, CA, NC & VA",
      "state": "MA",
      "product_description": "Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices:    1) NxStage One, Model NX1000-1;  2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A;  3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A;  4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;",
      "report_date": "20191225",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "NxStage Medical, Inc.",
      "recall_number": "Z-0697-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "83706",
      "termination_date": "20210201",
      "more_code_info": "",
      "recall_initiation_date": "20190827",
      "postal_code": "01843-1748",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}