{
  "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-1663-2018",
      "product_description": "Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 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 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  400792  402108  718349  719336  720207  724491  724820  725718  725967  728874  728899  732513  734021  734895  736505  737537  743970  745479  745645  746786  746958  749627  753240  755355  755385  757870  759563  762135  763024  765577  766622  769032  769488  778233  782558  786281  786340  786870  787341  792737  795834  796263  800153  800502  801288  802530  805121  805471  805801  806919  807211  813520  814347  814382  815314  816930  820150  820359  822492  825071  825229  825451  826055  826627  828591  828705  829397  830727  831128  831212  831302  831547  831565  832787  833304  834044  834712  835095  835382  835391  836112  836152  837841  838434  838774  839173  840083  840954  842022  842183  845112  845156  847861  847901  848231  848841  849061  849254  849944  850141  850340  851569  852394  852641  852892  853302  853382  853786  854089  855099  855122  855273  856674  856866  859951  860191  860303  862042  863777  865269  865418  865580  865720  866428  867262  868826  869057  869182  869234  869974  871376  871764  871877  872071  872863  873254  873259  874491  878338  879016  880653  880795  880832  880843  880964  881244  881617  881705  881777  881918  882789  883187  883398  883416  883633  884068  884237  886454  887689  889858  890428  890758  894234  894348  894617  895900  898761  901813  904457  905119  906737  907869  908249  909244  912418  912732  915132  915423  916017  919364  920356  925142  927197  928329  929730  930711  936707  938183  939798  940023  940386  940611  942273  943001  943885  943973  944249  946995  953811  954927  957053  959168  959347  960426  962828  963374  963861  964644  965116  973423  974215  977054  977058  978363  982851  988268  989495  990271  990388  991778  992782  993040  993151  993935  994571  994836  995376  998593  1000562  1000614  1000881  1001843  1002586  1013602"
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