U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Staple, removable (skin) - Product Code GDT
원인
Some boxes are labeled as containing visistat wide devices, when they in fact they contained visistat regular device.
조치
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.
Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
제품 설명
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, || Visistat 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