{
  "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": "36407",
      "product_res_number": "Z-0397-05",
      "event_date_initiated": "2004-12-23",
      "event_date_posted": "2005-01-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-11",
      "res_event_number": "30693",
      "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",
      "code_info": "Units with software version 8.7 used with Physioneal Clear-Flex PD products",
      "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": "A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.",
      "root_cause_description": "Other",
      "action": "Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04.  The patients in Denmark and Sweden will be  re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs.  Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use.  Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented.  The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.",
      "product_quantity": "165 units",
      "distribution_pattern": "Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.",
      "openfda": {
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          "K123630",
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        "registration_number": [
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        "fei_number": [
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          "3031565407",
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        "device_name": "System, Peritoneal, Automatic Delivery",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}