{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "35595",
      "product_res_number": "Z-0188-05",
      "event_date_initiated": "2004-11-01",
      "event_date_posted": "2004-11-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-11",
      "res_event_number": "30274",
      "product_code": "FKX",
      "k_numbers": [
        "K012988"
      ],
      "product_description": "HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441R",
      "code_info": "All units that do not bear the CE marking.",
      "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": "The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.",
      "root_cause_description": "Other",
      "action": "Baxter sent Urgent Device Correction letters to the Peritoneal Dialysis Home Care Coordinators on 11/1/04 and to the Home Dialysis Patients on 11/2/04.  The consignees were informed of the potential for a shock if the power switch loosens in the housing, and that the switch would be replaced with a grounded power switch on a next service call basis.  If the patient experiences any difficulty turing the device on or off, or if they notice that the power switch is loose, they were instructed to immediately unplug the device and contact Baxter Global Technical Service (BGTS) at 1-800-553-6898, option 1, for immediate assistance.",
      "product_quantity": "12,200 units",
      "distribution_pattern": "Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, Uruguay and Venezuela.",
      "openfda": {
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          "1000434163",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}