Simplifying Global Compliance
FDAnews Device Daily Bulletin
China Department of Health Issues Recall for Stent System
Feb. 3, 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.
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