{
  "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-1664-2018",
      "product_description": "Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL    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  709860  735355  743891  749663  753665  757109  763909  768077  774906  776397  780931  785500  789177  791625  792667  794258  797835  798697  799183  801072  802788  803224  804175  804202  804235  804561  804988  806824  811741  812442  812989  813180  844637  844720  845844  846093  846115  858309  864606  864957  870921  872713  872941  873294  873296  873302  877416  879360  883764  885021  905402  910300  912661  914647  915558  921852  923011  923362  923483  923990  926408  926680  927374  927490  927810  927848  928705  929190  929572  929887  930694  930914  930972  931613  931745  932170  932315  932496  932601  933050  933625  933745  934174  934407  934629  934656  934684  934685  935474  935554  935636  936378  936422  937342  938176  938742  939342  939364  939571  942194  945100  962029  965017  965310  967527  982596  983087  996433  996840  997035  997317  999136  1000594  1006058  1006935  1008672  1011288  1011482  1012217  1012228  1012708  1012883  1013017  1013180  1013371  1013628  1015173  1015537  1015796  1015902  1016229  1016277  1016287  1017064  1017616  1017627"
    }
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}