Z-1511-2025 Class II Ongoing

Recalled by Cordis US Corp — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
April 9, 2025
Initiation Date
March 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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.

Distribution Pattern

US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

Code Information

Lot # 18298568/UDI:(01)20705032024430