{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Republic",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93204",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "address_2": "N/A",
      "postal_code": "65738-2758",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "MO",
      "recall_number": "Z-0315-2024",
      "product_description": "Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit",
      "product_quantity": "134 units",
      "reason_for_recall": "Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige.  The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.",
      "recall_initiation_date": "20230921",
      "center_classification_date": "20231116",
      "report_date": "20231122",
      "code_info": "a) UDI/DI 10194717111702, Lot Numbers:  94114, 95436;  b) UDI/DI 10194717117049, Lot Numbers: 96442"
    }
  ]
}