{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "78607",
      "product_res_number": "Z-0745-2010",
      "event_date_initiated": "2009-01-29",
      "event_date_posted": "2010-01-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-16",
      "res_event_number": "51104",
      "product_code": "OEZ",
      "product_description": "Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.\n\nIntended for fluid management convenience when catheterization is required.",
      "code_info": "Lot number: F565427.",
      "firm_fei_number": "1721504",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 West Merit Parkway",
      "city": "South Jordan",
      "state": "UT",
      "postal_code": "84095",
      "additional_info_contact": "801-253-1600",
      "reason_for_recall": "A manufacturing defect may prevent adequate sterilization of the entire device.",
      "root_cause_description": "Process control",
      "action": "Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm.\n\nFor further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.",
      "product_quantity": "20 units",
      "distribution_pattern": "Worldwide Distribution -- United States ( PA and TX) and Japan.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
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    }
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}