{
  "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,
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  "results": [
    {
      "cfres_id": "150161",
      "product_res_number": "Z-0632-2017",
      "event_date_initiated": "2016-09-23",
      "event_date_posted": "2016-11-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-27",
      "res_event_number": "75367",
      "product_code": "OJV",
      "product_description": "Manifold Kit. Catalog Number K09-11867AP",
      "code_info": "Lot Number: H996495",
      "firm_fei_number": "1721504",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "city": "South Jordan",
      "state": "UT",
      "postal_code": "84095-2416",
      "additional_info_contact": "Ileana Davis\n801-253-1600",
      "reason_for_recall": "Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.",
      "root_cause_description": "Process control",
      "action": "Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.",
      "product_quantity": "40 units",
      "distribution_pattern": "Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.",
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        "device_name": "Single Use Instrument Tray",
        "medical_specialty_description": "General, Plastic Surgery",
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        "device_class": "1"
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