{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "220734",
      "product_res_number": "Z-2704-2026",
      "event_date_initiated": "2026-06-01",
      "event_date_posted": "2026-07-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99069",
      "product_code": "OEZ",
      "product_description": "Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A",
      "code_info": "REF/UDI-DI Box:Unit/Lot(Expiration):\n008416A/20886333217636:00886333217632/11656898(7/19/2027);\t\n008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)",
      "firm_fei_number": "1625425",
      "recalling_firm": "Argon Medical Devices, Inc",
      "address_1": "1445 Flat Creek Rd",
      "city": "Athens",
      "state": "TX",
      "postal_code": "75751-5002",
      "additional_info_contact": "Scott Bishop\n469-430-0546",
      "reason_for_recall": "Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 6/1/2026, correction notices were sent to customers who were asked to do the following:\n\n1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice\n2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified:\n- Place a copy of this notice with the affected product\n- Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine.\n3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures.\n4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure.\n5) Complete and return the response form via email Arbee.cummings@argonmedical.com",
      "product_quantity": "950",
      "distribution_pattern": "Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}