{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "204649",
      "product_res_number": "Z-0596-2024",
      "event_date_initiated": "2023-11-20",
      "event_date_posted": "2024-01-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-05",
      "res_event_number": "93525",
      "product_code": "OXQ",
      "product_description": "Regard Dressing change kit, Item Number 800026006",
      "code_info": "UDI/DI 10194717107873, Lot Numbers:  98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270",
      "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": "ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "ROi CPS issued an URGENT MEDICAL DEVICE CORRECTION NOTICE  to its sole consignee on 11/27/2023 via email.  The notice explained the problem, potential risk, and requested the following actions: \n1.\tCHECK: Please review your inventory to determine if the manufacturer item number and lot numbers listed in the above table are in your inventory.\n2.\tQUARANTINE: Segregate and quarantine all affected kits listed above. Do not further distribute.\n3.\t\tREMOVE: The affected Cardinal Health item 1022-(100ML Sterile Saline Irrigation bottle), attached to the outside of the affected kits as a piggy back prior to use or further distribution. The remainder of the kit is not affected and can be distributed/used after the 100 ML Saline Irrigation Bottle is removed.\n4.\tREPLY: Please indicate your understanding and completion of the instructions above by completing and returning the attached reply form.\na.\t\tComplete the section confirming destruction of the sterile saline irrigation bottles removed from the outside of the kit, if applicable, and discard according to your institution's disposal procedures.\nb.\t\tComplete and return the reply form even if you do not have any affected inventory at your facility to acknowledge receipt of the notices.\nc.\tPlease return the reply form to lacy.stewart@roiscs.com.\n5.\tNOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from Cardinal Health, and the initial recall issued by Nurse Assist in your communication.\n6.\tEND USERS: End user facilities are to follow the instructions above and complete and return the reply form indicating their understanding and compliance with the required actions, including the destruction of the Sterile Saline Irrigation Bottles.",
      "product_quantity": "1830 units",
      "distribution_pattern": "US Nationwide distribution in the state of Louisiana.",
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        "device_name": "Dressing Change Tray",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5075",
        "device_class": "1"
      }
    }
  ]
}