{
  "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": "44979",
      "product_res_number": "Z-0831-06",
      "event_date_initiated": "2006-03-29",
      "event_date_posted": "2006-05-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-02-26",
      "res_event_number": "34943",
      "product_code": "KPF",
      "k_numbers": [
        "K990953"
      ],
      "product_description": "Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085",
      "code_info": "version 2.0 -  HD Modules, PD Modules and Medical Record Modules only",
      "firm_fei_number": "3000210122",
      "recalling_firm": "Baxter Healthcare Renal Div",
      "address_1": "1620 Waukegan Rd Bldg R Mc Gaw",
      "city": "Park",
      "state": "IL",
      "postal_code": "60085-6730",
      "additional_info_contact": "Center for One Baxter \n800-422-9837",
      "reason_for_recall": "Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.",
      "root_cause_description": "Other",
      "action": "Baxter sent Urgent Device Correction letters dated 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules.  The letters indicated in a table which software anomalies were associated with the affected software modules in each software version.  A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued.  Individual customer training will be performed at each facility for those issues identified in the letter specific to their software version.  At that time the mitigation provided in the letter will be reviewed with the customer.",
      "product_quantity": "12 - U.S, 104 - International",
      "distribution_pattern": "Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.",
      "openfda": {
        "k_number": [
          "K791584",
          "K874020",
          "K802831",
          "K875121",
          "K790091",
          "K990953",
          "K791676",
          "K955762",
          "K821328",
          "K970989",
          "K061515",
          "K800496",
          "K913515"
        ],
        "registration_number": [
          "1649518",
          "1225714"
        ],
        "fei_number": [
          "3001236277",
          "3001451489"
        ],
        "device_name": "System, Dialysate Delivery, Semi-Automatic, Peritoneal",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}