{
  "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,
      "total": 1
    }
  },
  "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-2835-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "32855 kits",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000046316  3000047161  3000047162  3000048615  3000049262  3000049914  3000050929  3000051380  3000052645  3000054090  3000055099  3000056537  3000059946  3000061447  3000062406  3000065986  3000066489  3000066764  3000066770  3000068730  3000069160  3000069376  3000071293  3000071739  3000073191  3000073277  3000074271  3000075134  3000075676  3000076957  3000079650  3000081778  3000084071  3000084788  3000084789  3000086924  3000085291  3000087368  3000088278  3000088570  3000090526  3000090664  3000092443  3000096052  3000097302  3000098997  3000101522  3000103209  3000106823  3000110212  3000111023  3000112113  3000058895  3000064045  3000073190  3000077204  3000084689  3000086162  3000089349  3000094526  3000103212  3000110211  3000046315  3000047053  3000047709  3000048710  3000049479  3000050215  3000050930  3000051379  3000052646  3000054089  3000055098  3000056438  3000060258  3000060259  3000061292  3000063264  3000064522  3000066679  3000065125  3000065984  3000065985  3000066515  3000066680  3000067692  3000069161  3000069872  3000069873  3000071217  3000071891  3000073192  3000074272  3000075133  3000076154  3000076956  3000079648  3000079649  3000080226  3000081779  3000083059  3000084153  3000086058  3000087369  3000088277  3000089284  3000090665  3000092442  3000094528  3000094531  3000096053  3000096054  3000098998  3000098999  3000101523  3000103210  3000106825  3000107337  3000111022  3000112114  3000046411  3000069162  3000069442  3000071837  3000094141  3000111134  3000094151  3000094527  3000096001  3000099000  3000103211  3000106824  3000107336  3000111191  3000112115"
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}