{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "106520",
      "product_res_number": "Z-0826-2012",
      "event_date_initiated": "2011-12-14",
      "event_date_posted": "2012-01-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-17",
      "res_event_number": "60807",
      "product_code": "FKR",
      "k_numbers": [
        "K080919",
        "K111174"
      ],
      "product_description": "NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx\n\nThe NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.",
      "code_info": "Lot 1117911, Exp. 2013-09",
      "firm_fei_number": "3003464075",
      "recalling_firm": "NxStage Medical, Inc.",
      "address_1": "439 S Union St Fl 5th",
      "city": "Lawrence",
      "state": "MA",
      "postal_code": "01843-2837",
      "additional_info_contact": "978-687-4700",
      "reason_for_recall": "Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System",
      "root_cause_description": "Employee error",
      "action": "On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an \"IMPORTANT MEDICAL DEVICE RECALL\" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. \n\nIf you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).",
      "product_quantity": "1,192 devices",
      "distribution_pattern": "Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K800772",
          "K080919",
          "K810605",
          "K810127",
          "K802465",
          "K111174",
          "K850435",
          "K850756",
          "K060296",
          "K781303",
          "K140571",
          "K043436"
        ],
        "registration_number": [
          "9616074",
          "1649518",
          "3003464075"
        ],
        "fei_number": [
          "3001236277",
          "3002654698",
          "3003464075"
        ],
        "device_name": "Subsystem, Proportioning",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2"
      }
    }
  ]
}