{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Medina",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80355",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "711 Park Ave",
      "address_2": "N/A",
      "postal_code": "14103-1036",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI.",
      "recall_number": "Z-1248-2019",
      "product_description": "Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.",
      "product_quantity": "158",
      "reason_for_recall": "The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.",
      "recall_initiation_date": "20180621",
      "center_classification_date": "20190502",
      "termination_date": "20190523",
      "report_date": "20190508",
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