Device product
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Z-1510-2025
Product summary
- Firm
- Cordis US Corp
- Event
- Event 96418
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1510-2025
Official wording
Reason: product mix-up; Vascular stent labeled as one size but contains a different size.
Code information: Lot: 18298569/UDI: (01)20705032024591
Distribution pattern: US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Derived failure modes
-
Unknown
product mix-up; Vascular stent labeled as one size but contains a different size.