FDA-Device2025-04-09Class II
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Cordis US Corp
Hazard
product mix-up; Vascular stent labeled as one size but contains a different size.
Sold states
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Affected count
20 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2025Don't want to check this manually?
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