{
  "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": {
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  "results": [
    {
      "cfres_id": "94901",
      "product_res_number": "Z-0165-2011",
      "event_date_initiated": "2010-09-22",
      "event_date_posted": "2010-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-09-15",
      "res_event_number": "56908",
      "product_code": "HBT",
      "k_numbers": [
        "K091987"
      ],
      "product_description": "LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size\nModels:\n4007-03 Large size 3 Pack\n4008-03 Large size 10 Pack\n4007-07 Large size 1 Pack\nManufactured by LeMatire Vascular Inc, Burlington, MA 01803",
      "code_info": "Lot Number       Expiration Date  AGC1015          2012-10 AGC1016          2012-10 AGC1017          2012-10 AGC1018          2012-11 AGC1019          2012-11 AGC1022          2012-11 AGC1023          2012-11 AGC1024         2012-12 AGC1025         2013-01 AGC1027        2013-01 AGC1028       2013-01",
      "firm_fei_number": "1220948",
      "recalling_firm": "Lemaitre Vascular, Inc.",
      "address_1": "63 2nd Ave",
      "city": "Burlington",
      "state": "MA",
      "postal_code": "01803-4413",
      "additional_info_contact": "Same \n781-221-2266 Ext. 158",
      "reason_for_recall": "Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while the device inside was either a Medium or Large size.",
      "root_cause_description": "Packaging change control",
      "action": "LeMaitre Vascular issued an Urgent AnastoClip GC Device Field Safety Notice letter dated Sepember 28, 2010 identifying the affected devices and actions to be taken by customers. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. The letter provides an option for the notified hospital to return the affected product for replacement if unused or if they simply wish to have it corrected. \nCustomers can contact LeMaitre Customer Service for replacement at 800 628-9470.",
      "product_quantity": "108 units",
      "distribution_pattern": "Nationwide Distribution: to the states of CA, FL, GA, IL, IN, LA, MD, MS, NJ, OK, OR, and TX.",
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        "device_name": "Applier, Hemostatic Clip",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      }
    }
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}