{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Deerfield",
      "address_1": "1 Baxter Pkwy",
      "reason_for_recall": "A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.",
      "address_2": "",
      "product_quantity": "15,517 units (US: 9560; Canada: 5957)",
      "code_info": "Contact CDRH for list of affected serial numbers (15,517).",
      "center_classification_date": "20161129",
      "distribution_pattern": "Nationwide Distribution, Puerto Rico and Canada",
      "state": "IL",
      "product_description": "Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library,  V8 Spectrum Infusion Pump, Product Code 35700BAX2,  Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE:  The speakers are a part of the rear case assembly located in the back of the infusion pump.  The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.",
      "report_date": "20161207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Baxter Healthcare Corp.",
      "recall_number": "Z-0671-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75311",
      "termination_date": "20180615",
      "more_code_info": "",
      "recall_initiation_date": "20160928",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}