Cordis Corporation recalls Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictur…

Recall date

November 15, 2017

Source

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

Recall number

Z-0324-2018

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.

Why it was recalled

Potential for cracked luer hubs

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

What was recalled

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.