Device product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Z-0024-2025
Product summary
- Event
- Event 95329
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 devices
- Official record key
device-enforcement:Z-0024-2025
Official wording
Reason: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Code information: UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
Distribution pattern: US Nationwide distribution in the states of FL, MA, MI, OH, WA.
Derived failure modes
-
Unknown
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.