{
  "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-2834-2020",
      "product_description": "Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit,  P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09.   Product Usage: Indications For  Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.",
      "product_quantity": "13335 WW",
      "reason_for_recall": "Potential Endotoxin Contamination",
      "recall_initiation_date": "20200727",
      "center_classification_date": "20200821",
      "report_date": "20200902",
      "code_info": "Kit Lot Number:   3000045657  3000047164  3000048708  3000049477  3000050927  3000051753  3000051754  3000052790  3000053815  3000053816  3000056436  3000058893  3000059906  3000063263  3000064521  3000065233  3000066677  3000067689  3000071413  3000072399  3000074269  3000075922  3000077813  3000080874  3000081078  3000083096  3000084472  3000084787  3000086850  3000087366  3000088618  3000089991  3000090768  3000094337  3000097300  3000098247  3000099929  3000102977  3000106755  3000110208  3000111136  3000058894  3000070665  3000073189  3000077203  3000080875  3000084690  3000086792  3000089348  3000094338  3000103213  3000110209  3000045656  3000047710  3000048709  3000049478  3000050926  3000051752  3000052791  3000053817  3000056437  3000059907  3000061290  3000061291  3000064520  3000065234  3000065987  3000066678  3000067690  3000068924  3000069876  3000071218  3000071977  3000071978  3000073188  3000074270  3000076924  3000077812  3000080877  3000081077  3000083095  3000086851  3000087367  3000088617  3000090767  3000092537  3000094336  3000097301  3000098248  3000099928  3000102978  3000106754  3000110207  3000111137  3000046410  3000083097  3000111135  3000103214  3000110210  3000111192"
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}