FDAnews
www.fdanews.com/articles/143686-china-department-of-health-issues-recall-for-stent-system

China Department of Health Issues Recall for Stent System

February 2, 2012
The Chinese Department of Health has issued a field safety notice for Cordis’ S.M.A.R.T. Control Nitinol stent system due to a sterility breach in all pouches of the stent system. The defect was detected during in-house testing on non-production product as part of a development project.