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Teleflex Medical recalls WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Vi
Recalled December 21, 2016 · FDA recall Z-0764-2017 · Teleflex Medical
Hazard
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. · FDA Class II
Units
96,402 units (9,120 ea US, 87,282 ea OUS)
Sold at
Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
Description
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Product
WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close 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 →