{
  "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": "2026-04-08",
    "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": "79815",
      "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 & Puerto Rico",
      "recall_number": "Z-1665-2018",
      "product_description": "Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR    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 includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The 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.",
      "product_quantity": "444 units in total",
      "reason_for_recall": "Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.",
      "recall_initiation_date": "20180403",
      "center_classification_date": "20180504",
      "termination_date": "20200214",
      "report_date": "20180516",
      "code_info": "Serial numbers     745365  750241  750330  752814  754975  757930  762405  763117  764490  768855  772652  773031  773134  773520  774413  778845  779430  779822  781545  782706  782985  783185  787001  793146  833195  865842  883498  883854  889556  889775  890230  891398  891421  891647  891689  901881  917897  917963  919594  919736  919837  921078  921819  924734  928406  937123  940345  940860  940949  941786  944619  966019  990542  996435  996823  997156  998126  1011229  1011544  1014955  1027799"
    }
  ]
}