{
  "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,
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  "results": [
    {
      "cfres_id": "25532",
      "product_res_number": "Z-0565-03",
      "event_date_initiated": "2002-12-23",
      "event_date_posted": "2003-02-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-11",
      "res_event_number": "25284",
      "product_code": "FKX",
      "k_numbers": [
        "K012988"
      ],
      "product_description": "HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R",
      "code_info": "All HomeChoice PRO Systems with software versions 8.51 and 8.52.",
      "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": "Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy",
      "root_cause_description": "Other",
      "action": "Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines.  The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.",
      "distribution_pattern": "Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}