{
  "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": "Buffalo",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89810",
      "recalling_firm": "Graphic Controls Acquisition Corporation",
      "address_1": "400 Exchange St",
      "address_2": "N/A",
      "postal_code": "14204-2064",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.",
      "recall_number": "Z-0937-2022",
      "product_description": "CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US  Model: 32028778 50601-US",
      "product_quantity": "19470 units",
      "reason_for_recall": "Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c.  when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.",
      "recall_initiation_date": "20220315",
      "center_classification_date": "20220414",
      "termination_date": "20240712",
      "report_date": "20220420",
      "code_info": "All lots   UDI: 03700506307333"
    }
  ]
}