{
  "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": "26145",
      "product_res_number": "Z-0661-03",
      "event_date_initiated": "2003-02-20",
      "event_date_posted": "2003-03-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-03-27",
      "res_event_number": "25607",
      "product_code": "FKP",
      "k_numbers": [
        "K883111"
      ],
      "product_description": "Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015",
      "code_info": "catalog #5M5538, 5M5538R, 5M5551, 5M5551R, 5M5575, FM4719, FM4774, FM4779, FM4779R; all serial numbers",
      "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": "Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)",
      "root_cause_description": "Other",
      "action": "Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure.  The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed.  Changes to the instructions for use are in process and will be sent to the end users when completed.\n\nAdditionally, the Baxter 1550 has a side panel that contains a 16-digit display.  Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'.  To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs.  The SPS 550 does not have the side panel display and does not require the software upgrade.",
      "distribution_pattern": "Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, 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"
        ]
      }
    }
  ]
}