Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
FDA Recall #Z-1511-2025 — Class II — March 4, 2025
Product Description
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 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
1 unit
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Code Information
Lot # 18298568/UDI:(01)20705032024430
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated