{
  "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": "139761",
      "product_res_number": "Z-0044-2016",
      "event_date_initiated": "2015-04-22",
      "event_date_posted": "2015-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-28",
      "res_event_number": "71904",
      "product_code": "FSY",
      "product_description": "regard Item Number: 800508, Sterile, LD0586 - C Section -  surgical kit containing cover light handle soft, RX.  The responsible firm on the label is ROi, LLC, St. Louis, MO.\r\nCustom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure",
      "code_info": "Lot numbers 16153, 19010, 19989, 21287, and 21831.",
      "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": "The kits contain an equipment glove component which may contain splits or holes compromising the sterility.",
      "root_cause_description": "Process control",
      "action": "ROi initiated a recall of the custom kits via e-mail to their customers on April 22, 2015.   The e-mail included their recall letter dated April 17, 2015. and the supplier's recall letter dated April 16, 2015.  The customer was requested to discard the recalled component from their procedure tray at the time of set up and replace it with sterile stock.  Customers were instructed to contact any ROi custom pack solutions manager with any concerns.   The recalling firm issued a second e-mail notification on 10/19/2015 to the recall coordinator of the distributor.  The notice informed them they had been receiving uncorrected product and reminded them to discard the defective component at the time the kit is set up for surgery.  Any future distribution will be labeled with an alert to remove the defective component until the kits contain acceptable light handle covers.\r\n\r\nFor questions regarding this recall call 314-364-6561.",
      "product_quantity": "146 kits",
      "distribution_pattern": "Distribution was made to LA, MS, and TX.",
      "openfda": {
        "k_number": [
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        "registration_number": [
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        "fei_number": [
          "1000182014",
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        ],
        "device_name": "Light, Surgical, Ceiling Mounted",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4580",
        "device_class": "2"
      }
    }
  ]
}