{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221566",
      "product_res_number": "Z-2964-2026",
      "event_date_initiated": "2026-07-10",
      "event_date_posted": "2026-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99443",
      "product_code": "OKV",
      "product_description": "Halyard LAVH PACK, Model/Catalog Number: USAR053-11",
      "code_info": "UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027",
      "firm_fei_number": "1047429",
      "recalling_firm": "AVID Medical, Inc.",
      "address_1": "9000 Westmont Dr",
      "city": "Toano",
      "state": "VA",
      "postal_code": "23168-9351",
      "additional_info_contact": "Marlene Jones\n757-566-3510",
      "reason_for_recall": "A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.",
      "root_cause_description": "Process control",
      "action": "Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 7/10/2026 via email.  The notice explained the issue, potential risks to health, and requested the following:  \n\"ACTIONS TO TAKE:\n  \" DO NOT USE AND DISCARD the Clearify Visualization System (Component# 5303907) located in the convenience kit identified in Table 1 above. All other components in the kits may continue to be used.\n  \" Add warning labels to affected AVID kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Please contact your Sales Representative if pre-printed labels are needed.\n    \" Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n    \" Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n    \" Complete the attached Recall Response Form and return by July 22, 2026.\"",
      "product_quantity": "40 packs",
      "distribution_pattern": "US Nationwide distribution in the state of TX.",
      "openfda": {
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        ],
        "device_name": "Obstetrical Kit",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4520",
        "device_class": "2"
      }
    }
  ]
}