{
  "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,
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  "results": [
    {
      "cfres_id": "170566",
      "product_res_number": "Z-0960-2019",
      "event_date_initiated": "2018-07-03",
      "event_date_created": "2019-02-27",
      "recall_status": "Terminated",
      "res_event_number": "82015",
      "product_code": "MAV",
      "k_numbers": [
        "K962495"
      ],
      "product_description": "PLUS 30 PRIORITY PACK Accessory Kit\n\nProduct Usage:\nIs recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).",
      "code_info": "Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593",
      "firm_fei_number": "2024168",
      "recalling_firm": "Abbott Vascular",
      "address_1": "26531 Ynez Rd",
      "city": "Temecula",
      "state": "CA",
      "postal_code": "92591-4630",
      "additional_info_contact": "Customer Service \n800-227-9902",
      "reason_for_recall": "Incorrect expiration being entered for one lot.",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "Abbott Vascular sent an Urgent Field Safety Notice/ Device Recall  letter dated  July 3, 2018 to affected customers.  The letter identified the affected product, problem and actions to be taken.  The letter instructed customers to:\n\" Review inventory and stop using affected devices.\n\" Complete and return the attached Effectiveness Check Form\n\" Return the unused identified products to Abbott Vascular\n\" Share this notification with other relevant personnel in their organization\n\nFor questions contact Abbott Representative or Customer Service department on 800-227-9902.",
      "product_quantity": "26 units",
      "distribution_pattern": "US Nationwide Distribution - NC and NY",
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        "device_name": "Syringe, Balloon Inflation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}