Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
FDA Recall #Z-1510-2025 — Class II — March 4, 2025
Product Description
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason for Recall
product mix-up; Vascular stent labeled as one size but contains a different size.
Recalling Firm
Cordis US Corp — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20 units
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Code Information
Lot: 18298569/UDI: (01)20705032024591
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated