Device product
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Z-0499-2025
Product summary
- Event
- Event 95582
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0499-2025
Official wording
Reason: Devices from the affected device lots have labels that state the incorrect expiration dates.
Code information: UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Distribution pattern: International Distribution to: Korea only
Derived failure modes
-
Unknown
Devices from the affected device lots have labels that state the incorrect expiration dates.