{
  "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": "Saint Paul",
      "address_1": "1225 Old Highway 8 NW",
      "reason_for_recall": "Cardiovascular Systems, Inc. (CSI). has initiated a  recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017.  The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.",
      "address_2": "",
      "product_quantity": "1,396",
      "code_info": "Lot Number  92254  92693  106281  106282  106283  106284  106285  106286  106287  106288  106290  106543  118121  118223  121782  123165  123489  123547  123808  123878  124088  124289  124925  124927  124989  125310  125347  125362  126696  126797  126925  127026  127155  127221  127348  127614  127742  127834  128001  128027  128132  128179  128326  129266  129303  132418  132839  132966  133231  133429  133759  133880  134057  134318  134534  134966  135199  135372  135791  135941  136729  136881  136883  137221  137361  137657  137862  138218  138462  138614  139049  139295  139621  140470  140606  142474  142596  142604  142909  143084  143213  143277  143335  143419  143553  143556  143806  144066  144276  144496  145536  145946  146051  146199  146337  146401  146518  146843  146999  147508  147530  148129  148169  148400  148712  148897  149117  149268  149527  150273  150285  150774  150831  151196  151228  151440  151635  151867  151994  152092  152178  152321  152389  152522  152889  153280  153678  154011  154434  154682  154948  155270  156044  156340  156683  156713  157869  158004  152178  152321  158124  158234  158370  158422  158558  158617  160312  160352  160995  161165  161241  161328  161466  161603  161679  161774  161892  162318  162344  162384  162402  162421  162439  163493  163600  164048  164293  164561  164873  165087  165353  165811  165971  166068  166226  166653  166863  166907  167024  167115  167146  168006  168048  168052  168087  168093  168143  168173  168589  169662  170066  170315  170350  170385  171566  171679  171915  172145  172379  172490  172491  172755  172859  172871  173226  173486  173783  174051  174434  174621  174637  174659  175087  175167  176653  177218  177359  177385  177625  178212  178237  178742  179133  179287  179558  179602  179649  179955  180225  180360  180463  180629  181317  181320  181556  181586  182441  182442  182494  182495  182537  182539  183099  183101  183150  183400  186393  186683  186820  186881  187241  187242  187398  101182a  101534A  102274a  103369a  104183B  105371a  106346A  106346b  108335A  110016A  111785a  111785b  114148a  114964a  49267-4A  50805A  50805a  50891A  50949A  50949B  51191A  51344A  51345A  51498A  51498B  51570A  51571a  51725A  52006A  52089A  52090B  52253A  52258A  52258b  52347A  52377A  52378A  52666a  52890a  52907A  52908a  52915B  52915C  52963A  52968a  53675B  53689A  53802A  53802B  54321A  54321B  54321C  54814A  54826A  54827A  54828A  54829A  54996A  55065B  55097A  55097B  55097C  55100A  55133A  55198A  55286a  55507a  55973A  56195A  56195B  56313A  56313B  56417A  56421A  56638A  56638B  56697A  56732A  56733A  56810A  56810B  56811A  56951A  56952A  57095a  57096A  57098B  57215A  57216A  57223A  57238A  57281A  57342a  57407A  57454A  57610A  57691A  57692a  57864A  57866a  57930A  57974A  57992B  58052A  58054A  58054B  58141A  58158A  58262A  58309A  58354a  58710A  58781A  58783a  62814A  62856A  62856B  62908A  63010A  63054A  63054B  63322B  63374A  63374B  63374C  63430A  63430B  63430c  64895A  66052A  66138A  66221a  66503a  66571A  67046a  67174A  67391A  67465A  67465b  67818a  67930a  67930b  68200A  68200b  68200C  68346a  68686A  68686b  68686c  69174A  69320A  69709A  69709B  69912A  70295A  70669A  70758A  70821A  71061a  71125A  71343A  71720A  71720B  71817A  71817B  71934A  72291A  72291B  72725a  72901a  73378A  73987A  74737A  75702a  76877a  77104a  77180A  77339A  77647a  77782A  77961A  78249A  78758A  80916A  81073A  81595A  81595b  81873a  82183B  85417A  86237A  86640A  87049A  92285a  97352A  98263A  99375A  99562a",
      "center_classification_date": "20170520",
      "distribution_pattern": "US: AK, AL, AR, AZ. , CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY,  OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI,     AUSTRIA, GERMANY, JAPAN, SWITZERLAND.",
      "state": "MN",
      "product_description": "CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only,  Part Number: 7-10014, Model Number: SIP-3000.",
      "report_date": "20170531",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cardiovascular Systems Inc",
      "recall_number": "Z-2122-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76953",
      "termination_date": "20171002",
      "more_code_info": "",
      "recall_initiation_date": "20170414",
      "postal_code": "55112-6416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}