{
  "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": {
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  "results": [
    {
      "cfres_id": "39627",
      "product_res_number": "Z-0139-06",
      "event_date_initiated": "2005-09-12",
      "event_date_posted": "2005-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-19",
      "res_event_number": "32323",
      "product_code": "FKX",
      "k_numbers": [
        "K012988"
      ],
      "product_description": "Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.",
      "code_info": "All Spanish language Patient At-Home Guides, with item numbers other than item #157-1260-806ES Rev. A 7/04 printed on teh back cover of the manual",
      "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 Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.",
      "root_cause_description": "Other",
      "action": "An Urgent Device Correction letter was sent in Spanish and English, along with the new Spanish Patient At-Home Guide, item 157-1260-806ES, to Spanish-only speaking customers and their affiliated facilities on 9/12/05.  The letters highlighted the additions to the Patient At-Home Guide and asked the customers to review them carefully and to use the new guide from this point forward to assist them in the safe and effective operation of their HomeChoice/HomeChoice PRO machine. They were instructed to discard any previous versions of the guide.  Any questions were directed to Baxter DIalysis Patient Services at 1-800-2824-4060.",
      "product_quantity": "524 manuals",
      "distribution_pattern": "Nationwide",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
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