{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Deerfield",
      "address_1": "1 Baxter Pkwy",
      "reason_for_recall": "In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP).  This can cause serious problems in patients with unrelated a co-morbid condition of ascites.",
      "address_2": "",
      "product_quantity": "*** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units",
      "code_info": "*** 1) HomeChoice automated peritoneal dialysis system:   Product Codes: 5C4471 and 5C4471R;   Serial Numbers: All serial numbers;     *** 2) HomeChoice Pro automated peritoneal dialysis system:   Product Codes: 5C8310 and 5C8310R;   Serial Numbers: All serial numbers",
      "center_classification_date": "20160822",
      "distribution_pattern": "Worldwide distribution.  US nationwide including Puerto Rico;  Australia, Canada, New Zealand, and Japan",
      "state": "IL",
      "product_description": "1) The HomeChoice automated peritoneal dialysis system.  Dataplate located on the device is labeled in part: Baxter.     2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter.    The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.",
      "report_date": "20160831",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Baxter Healthcare Corp.",
      "recall_number": "Z-2609-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66606",
      "termination_date": "20161223",
      "more_code_info": "",
      "recall_initiation_date": "20131007",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}