Z-0499-2025 Class II Ongoing
FDA device recall Z-0499-2025 was initiated by Cook Incorporated on October 14, 2024 and is designated Class II. Reason for recall: Devices from the affected device lots have labels that state the incorrect expiration dates. The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- October 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Reason for Recall
Devices from the affected device lots have labels that state the incorrect expiration dates.
Distribution Pattern
International Distribution to: Korea only
Code Information
UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020