{
  "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": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79965",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.",
      "recall_number": "Z-1922-2018",
      "product_description": "Prismaflex System, Product Code 107493     Intended Use: The Prismaflex Control Unit is intended for: \" Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. \" Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. \" Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.",
      "product_quantity": "5880 units",
      "reason_for_recall": "Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a  Voltage Out of Range  malfunction alarm, which causes the device to enter a  safe state  and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.",
      "recall_initiation_date": "20180424",
      "center_classification_date": "20180523",
      "termination_date": "20210622",
      "report_date": "20180530",
      "code_info": "All Lots and Serial Numbers"
    }
  ]
}