{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Maple Grove",
      "address_1": "6464 Sycamore Ct N",
      "reason_for_recall": "Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.",
      "address_2": "",
      "product_quantity": "3500 units",
      "code_info": "lots 27686, 27293, 22446",
      "center_classification_date": "20120917",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea.  Italy, Korea",
      "state": "MN",
      "product_description": "Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102.    Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105\") during diagnostic/interventional procedures.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Vascular Solutions, Inc.",
      "recall_number": "Z-2400-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63098",
      "termination_date": "20121204",
      "more_code_info": "",
      "recall_initiation_date": "20120830",
      "postal_code": "55369-6032",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}