{
  "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",
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      "product_res_number": "Z-2108-2017",
      "event_date_initiated": "2017-03-24",
      "event_date_created": "2017-05-17",
      "recall_status": "Completed",
      "res_event_number": "77102",
      "product_code": "GDT",
      "product_description": "WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO,  \nVisistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures",
      "code_info": "73H1600207",
      "firm_fei_number": "3005747797",
      "recalling_firm": "Teleflex Medical",
      "address_1": "2917 Weck Dr",
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      "state": "NC",
      "postal_code": "27709-0186",
      "additional_info_contact": "Elizabeth Norwood\n919-544-8000",
      "reason_for_recall": "Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.",
      "root_cause_description": "Error in labeling",
      "action": "Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees.  The letter requested that they check inventory on hand and quarantine product for return.  They letter also requested that distributors conduct a sub-recall.  The letter included a reply form to be returned.  Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.",
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