{
  "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 and Rear Case Assembly 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": "439 units",
      "code_info": "Product Code 35701; distributed between 02/04/2015 - 06/02/2015.",
      "center_classification_date": "20161129",
      "distribution_pattern": "Nationwide Distribution, Puerto Rico and Canada",
      "state": "IL",
      "product_description": "V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC 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.  Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump.  It is not a registered finished good.",
      "report_date": "20161207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Baxter Healthcare Corp.",
      "recall_number": "Z-0672-2017",
      "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"
    }
  ]
}