{
  "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": "Terminated",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84521",
      "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": "US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV    OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia",
      "recall_number": "Z-0932-2020",
      "product_description": "Reinforced Introducer Sets   Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.",
      "product_quantity": "102",
      "reason_for_recall": "Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets   Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.",
      "recall_initiation_date": "20191120",
      "center_classification_date": "20200201",
      "termination_date": "20210615",
      "report_date": "20200212",
      "code_info": "Part Number: 0684 00 0403 06  UDI: 10607567106656 (0684 00 0403 06)  Lot Codes: 3000051658, TLT"
    }
  ]
}