{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "41161",
      "product_res_number": "Z-0219-06",
      "event_date_initiated": "2005-05-17",
      "event_date_posted": "2005-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-07-06",
      "res_event_number": "32971",
      "product_code": "DQT",
      "k_numbers": [
        "K872090"
      ],
      "product_description": "Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray.  The product is labeled in part:  ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.",
      "code_info": "Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.",
      "firm_fei_number": "1220948",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "3101 37th Ave N",
      "city": "St Petersburg",
      "state": "FL",
      "postal_code": "33713-1509",
      "reason_for_recall": "LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.",
      "root_cause_description": "Other",
      "action": "The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.",
      "product_quantity": "1,919",
      "distribution_pattern": "There are two lots in distribution (175 pieces) that may contain the small hole in the tray.  These two lots  were distributed in Japan and Europe.  There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack.  These 16 lots were distributed in the United States, Canada, Japan and the European Union.",
      "openfda": {
        "k_number": [
          "K863559",
          "K844918",
          "K872790",
          "K872090",
          "K945963",
          "K840795",
          "K983927",
          "K910916",
          "K880231",
          "K872154",
          "K910339",
          "K880860"
        ],
        "registration_number": [
          "",
          "1220948",
          "3011137372",
          "1319639",
          "3010041511"
        ],
        "fei_number": [
          "",
          "1220948",
          "1000138054",
          "3005747797",
          "3010041511"
        ],
        "device_name": "Occluder, Catheter Tip",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1370",
        "device_class": "2"
      }
    }
  ]
}