{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139802",
      "product_res_number": "Z-0191-2016",
      "event_date_initiated": "2015-08-25",
      "event_date_posted": "2015-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-04-06",
      "res_event_number": "72052",
      "product_code": "LHC",
      "k_numbers": [
        "K142080"
      ],
      "product_description": "Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.",
      "code_info": "24634",
      "firm_fei_number": "3004513970",
      "recalling_firm": "Resource Optimization & Innovation Llc",
      "address_1": "2909 N Neergard Ave",
      "city": "Springfield",
      "state": "MO",
      "postal_code": "65803",
      "additional_info_contact": "Robert W. Callahan\n314-364-6561",
      "reason_for_recall": "Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.",
      "root_cause_description": "Packaging",
      "action": "On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier.\r\n\r\nOn September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.",
      "product_quantity": "10 kits",
      "distribution_pattern": "Distributed in Texas and Louisiana.",
      "openfda": {
        "k_number": [
          "K832642",
          "K933726",
          "K833944",
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          "K880252",
          "K023282",
          "K921633",
          "K023283",
          "K021289",
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        "device_name": "Warmer, Irrigation Solution",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5950",
        "device_class": "1"
      }
    }
  ]
}