{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "26530",
      "product_res_number": "Z-0833-03",
      "event_date_initiated": "2003-03-20",
      "event_date_posted": "2003-05-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-01-23",
      "res_event_number": "25818",
      "product_code": "FKP",
      "k_numbers": [
        "K910215"
      ],
      "product_description": "Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA",
      "code_info": "Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764",
      "firm_fei_number": "1416980",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "Rt 120 & Wilson Rd",
      "city": "Round Lake",
      "state": "IL",
      "postal_code": "60073",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.",
      "root_cause_description": "Other",
      "action": "Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03.  The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes.  These changes will prevent undetected acid-only delivery in the event of a sodium level change",
      "product_quantity": "25,014 units",
      "distribution_pattern": "The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.",
      "openfda": {
        "k_number": [
          "K873155",
          "K964264",
          "K910215",
          "K130460",
          "K003615",
          "K131739",
          "K894838",
          "K781886",
          "K850569",
          "K854479",
          "K761287",
          "K930181",
          "K904967",
          "K896758",
          "K800425",
          "K992255",
          "K851306",
          "K905388",
          "K863609",
          "K771065",
          "K800330",
          "K811591",
          "K181991",
          "K905793",
          "K770350",
          "K890824",
          "K922757",
          "K955423",
          "K864094",
          "K871218",
          "K792173",
          "K813432",
          "K861230",
          "K854367",
          "K953854",
          "K883111",
          "K781405",
          "K802880",
          "K853513",
          "K021060",
          "K802250",
          "K771696",
          "K864083",
          "K896757",
          "K850179",
          "K921456",
          "K040074",
          "K780682",
          "K880459",
          "K811972"
        ],
        "device_name": "System, Dialysate Delivery, Single Patient",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
          "3029754060",
          "2150060",
          "2132111"
        ],
        "fei_number": [
          "3029754060",
          "2150060",
          "1000140026"
        ]
      }
    }
  ]
}