{
  "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": {
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  "results": [
    {
      "status": "Terminated",
      "city": "Bergen Op Zoom",
      "state": "N/A",
      "country": "Netherlands",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87406",
      "recalling_firm": "Eight Medical International BV",
      "address_1": "Laan Van Hildernisse-Noord 2a",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide,  Colombia, and Dubai.",
      "recall_number": "Z-2005-2021",
      "product_description": "Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016.   Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.",
      "product_quantity": "22",
      "reason_for_recall": "The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.",
      "recall_initiation_date": "20210604",
      "center_classification_date": "20210723",
      "termination_date": "20230803",
      "report_date": "20210804",
      "code_info": "UDI: 08719992086016    Lot Numbers: 20021361  20202106  20202106  20018480  19854186  20019438  20018480  19854186  19854185  20202106  20019438  19854184  20202106  20018480  20202106  20018480  18687686"
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}