{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "203649",
      "product_res_number": "Z-0315-2024",
      "event_date_initiated": "2023-09-21",
      "event_date_posted": "2023-11-16",
      "recall_status": "Open, Classified",
      "res_event_number": "93204",
      "product_code": "OEZ",
      "product_description": "Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit",
      "code_info": "a) UDI/DI 10194717111702, Lot Numbers:  94114, 95436; \nb) UDI/DI 10194717117049, Lot Numbers: 96442",
      "firm_fei_number": "3014527682",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "city": "Republic",
      "state": "MO",
      "postal_code": "65738-2758",
      "additional_info_contact": "417-730-3900",
      "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.",
      "root_cause_description": "Other",
      "action": "ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email.  The email attached the notice and the notice received from Getinge.  The notice explained the issue, the potential risks, and requested the distributor notify their customer.  End user was directed to post the Getinge notice in area where the affect kits were used.  \n\nAn updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions.",
      "product_quantity": "134 units",
      "distribution_pattern": "MO",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}