{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85823",
      "recalling_firm": "Datascope Corporation",
      "address_1": "15 Law Dr",
      "address_2": "N/A",
      "postal_code": "07004-3206",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.",
      "recall_number": "Z-2833-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08     Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "31529 WW",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000046414  3000047431  3000048243  3000049080  3000049569  3000050495  3000051154  3000051751  3000053311  3000054591  3000054592  3000056356  3000056629  3000058277  3000060542  3000064249  3000066800  3000065563  3000067963  3000070668  3000071291  3000071979  3000073516  3000074146  3000075999  3000078921  3000080138  3000080137  3000081624  3000082197  3000082848  3000083430  3000084785  3000086995  3000087888  3000089898  3000091753  3000092239  3000092240  3000094450  3000094451  3000095604  3000096970  3000097957  3000100722  3000105063  3000102628  3000105064  3000107101  3000108962  3000109818  3000112782  3000046415  3000047430  3000048245  3000049085  3000049570  3000051153  3000051881  3000053310  3000054729  3000056538  3000059168  3000059618  3000060730  3000060451  3000064248  3000066798  3000065636  3000066799  3000067964  3000070669  3000071292  3000071980  3000073517  3000074144  3000074145  3000076000  3000078922  3000080140  3000082847  3000083431  3000083989  3000084730  3000087112  3000088376  3000089899  3000091754  3000092134  3000094449  3000095692  3000096971  3000097952  3000097953  3000100721  3000102697  3000105062  3000107100  3000109817  3000111681  3000113153  3000048244  3000049567  3000050496  3000051155  3000053312  3000054730  3000059169  3000060545  3000060543  3000066063  3000064842  3000064843  3000066801  3000066802  3000066803  3000076001  3000080543  3000080544  3000081621  3000082189  3000084786  3000086996  3000091755  3000092238  3000097956  3000102698  3000105060  3000106965  3000112155  3000112156  3000046416  3000047435  3000049568  3000056539  3000059619  3000064250  3000066804  3000066805  3000067857  3000070670  3000073518  3000074162  3000078923  3000080139  3000084731  3000097954  3000102699  3000108432  3000112154  3000103022  3000047356  3000048230  3000049055  3000051378  3000054590  3000056355  3000056628  3000059148  3000060544  3000068926  3000068941  3000073404  3000074166  3000074890  3000076131  3000076402  3000078920  3000080420  3000081777  3000083598  3000085937  3000090852  3000089347  3000091872  3000094108  3000094935  3000096067  3000095318  3000096066  3000097959  3000100857  3000100582  3000102905  3000105061  3000107102  3000108963  3000111680  3000113152  3000068029  3000071836  3000074163  3000103039  3000106964"
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