{
  "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-2832-2020",
      "product_description": "Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10  -Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "16104 WW",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000047433  3000048714  3000049793  3000053296  3000054596  3000055303  3000056631  3000060227  3000064257  3000070321  3000071835  3000072581  3000072582  3000076925  3000078405  3000079518  3000080107  3000083511  3000084721  3000087689  3000092131  3000092215  3000095792  3000096364  3000097534  3000100872  3000102116  3000106750  3000107623  3000112279  3000047432  3000047933  3000049794  3000052255  3000055306  3000056632  3000061197  3000064258  3000065635  3000066086  3000066265  3000067264  3000067841  3000068601  3000068602  3000074729  3000074850  3000079519  3000081079  3000080541  3000083512  3000084722  3000087474  3000087973  3000089282  3000092129  3000092130  3000095793  3000097645  3000096762  3000097644  3000097643  3000103157  3000104738  3000106751  3000107624  3000112280  3000047434  3000047523  3000048024  3000048025  3000049795  3000052254  3000053295  3000054426  3000054425  3000055305  3000059063  3000060228  3000061341  3000064844  3000072583  3000081622  3000082248  3000082188  3000083990  3000084723  3000099218  3000104736  3000104737  3000106752  3000047309  3000047934  3000049796  3000066797  3000074731  3000083513  3000079520  3000083514  3000095794  3000096366  3000102115  3000106753  3000112278  3000047355  3000048228  3000050257  3000052253  3000054424  3000055304  3000056630  3000059062  3000060229  3000061195  3000061196  3000064259  3000064355  3000066796  3000069443  3000070319  3000080729  3000077201  3000078053  3000078919  3000080419  3000083599  3000084691  3000085499  3000086793  3000086794  3000089346  3000091874  3000090851  3000091873  3000093117  3000093118  3000093119  3000094614  3000094613  3000095319  3000095854  3000096761  3000097533  3000099217  3000100871  3000102117  3000103158  3000104739  3000106898  3000107622  3000112281  3000114254  3000071786  3000073203  3000096365  3000103156"
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