{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Athens",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85488",
      "recalling_firm": "Argon Medical Devices, Inc",
      "address_1": "1445 Flat Creek Rd",
      "address_2": "N/A",
      "postal_code": "75751-5002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS:  None",
      "recall_number": "Z-1938-2020",
      "product_description": "PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for contralateral access to the iliac artery and selected vasculature.     Case Label:  PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EO",
      "product_quantity": "80",
      "reason_for_recall": "Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture.  The thicker suture may be more difficult to tie.  The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.",
      "recall_initiation_date": "20200408",
      "center_classification_date": "20200508",
      "termination_date": "20221214",
      "report_date": "20200520",
      "code_info": "Lot:  11299245"
    }
  ]
}