FDA-Device2018-01-17Class II
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.
Cordis Corporation
Hazard
Potential for cracked luer hubs
Sold states
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.
Affected count
511
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2018Don't want to check this manually?
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