{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "184211",
      "product_res_number": "Z-0418-2021",
      "event_date_initiated": "2020-10-14",
      "event_date_created": "2020-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-10-19",
      "res_event_number": "86627",
      "product_code": "DQR",
      "k_numbers": [
        "K051655"
      ],
      "product_description": "Angiodynamics 5F Standard Micro-Introducer Kit - indicated for\npercutaneous introduction of a guidewire or catheter into\nthe vascular system, Catalog Number: 06597035\nUPN: H787065970355",
      "code_info": "Lot Number: 5626935 Expiration Date: 08/31/2023",
      "firm_fei_number": "1319211",
      "recalling_firm": "Angiodynamics, Inc.",
      "address_1": "603 Queensbury Ave",
      "city": "Queensbury",
      "state": "NY",
      "postal_code": "12804-7619",
      "additional_info_contact": "SAME\n518-798-1215",
      "reason_for_recall": "5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component",
      "root_cause_description": "Under Investigation by firm",
      "action": "Angiodynamics initiated on October 14, 2020 Urgent Medical Device Recall Notification via Federal Express consignees. The recall letter states reason for recall, health risk and action to take:\nStop using the product subject to recall.\no Remove any affected (recalled) product from your inventory (whether in labs, Central Supply,\nShipping and Receiving or ANY other location).\no Segregate this product in a secure location for return to AngioDynamics, Inc.\no Forward a copy of this recall notification to all sites to which you have distributed affected product.\nIf affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-\n772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain a\nreplacement or credit for your returned product.\n\" Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not\nhave any product to return); following the directions on this page and the Reply Verification Tracking\nForm.",
      "product_quantity": "32 kits",
      "distribution_pattern": "US Nationwide distribution including in the states of AL, CT,  GA, FL.",
      "openfda": {
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          "K881884",
          "K870825",
          "K874618",
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          "K803002",
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          "K884478",
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          "9710524",
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        "device_name": "Cannula, Catheter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1300",
        "device_class": "2"
      }
    }
  ]
}