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Teleflex Medical recalls WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external sk
Recalled May 24, 2017 · FDA recall Z-2108-2017 · Teleflex Medical
Hazard
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. · FDA Class II
Units
3594 eaches
Sold at
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
Description
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Product
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
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →