Ethicon Endo-Surgery Inc recalls ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in…

Recall date

February 26, 2015

Source

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

Recall number

Z-1641-2015

FDA classification

Class II

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.

Why it was recalled

During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

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

What was recalled

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.