FDA-Device2017-05-24Class II
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
Teleflex Medical
Hazard
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Sold states
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
Affected count
3594 eaches
Manufactured in
2917 Weck Dr, Research Triangle Park, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2017Don't want to check this manually?
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