WECK Visistat 35W recalled over laceration hazard

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teleflex Medical recalls WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visis…

Recall number

Z-0764-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

Why it was recalled

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.