{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "country": "United States",
      "city": "South Jordan",
      "address_1": "1600 W Merit Pkwy",
      "reason_for_recall": "Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.",
      "address_2": "",
      "product_quantity": "1,265 total",
      "code_info": "Lot Numbers: H1041469, H1041473, H1036880, H1041464.",
      "center_classification_date": "20170324",
      "distribution_pattern": "Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.",
      "state": "UT",
      "product_description": "7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT.    Produc Usage:  The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.",
      "report_date": "20170405",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Merit Medical Systems, Inc.",
      "recall_number": "Z-1497-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76596",
      "termination_date": "20170808",
      "more_code_info": "",
      "recall_initiation_date": "20170216",
      "postal_code": "84095-2416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}