{
  "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": {
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  "results": [
    {
      "cfres_id": "167598",
      "product_res_number": "Z-0107-2019",
      "event_date_initiated": "2018-09-18",
      "event_date_created": "2018-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-19",
      "res_event_number": "81158",
      "product_code": "PHC",
      "k_numbers": [
        "K173084"
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      "product_description": "SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009",
      "code_info": "UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018",
      "firm_fei_number": "1314492",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "711 Park Ave",
      "city": "Medina",
      "state": "NY",
      "postal_code": "14103-1036",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the  Basic-Dose Mode,  the operator will receive a false  hard limit exceeded  error, preventing him or her from programming the infusion.",
      "root_cause_description": "Software design",
      "action": "The firm initiated their field correction by email on 09/14/2018.  The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue.",
      "product_quantity": "354 units",
      "distribution_pattern": "NJ",
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        "device_name": "Infusion Safety Management Software",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
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}