FDA recall Z-0324-2018

Product

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.

Reason for recall

Potential for cracked luer hubs

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-11-15

Report date

2018-01-17

Termination date

2019-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2018