FDA Enforcement
Class II
Ongoing
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Recall: Z-1510-2025
·
Reported April 9, 2025
Enforcement
- Recall Number
- Z-1510-2025
- Event ID
- 96418
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cordis US Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 9, 2025
- Initiation Date
- March 4, 2025
- Classification Date
- April 3, 2025
- Address
- 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802, United States
Description
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason
product mix-up; Vascular stent labeled as one size but contains a different size.
Code Info
Lot: 18298569/UDI: (01)20705032024591
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Quantity
20 units