Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
FDA Recall #Z-0499-2025 — Class II — October 14, 2024
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.
Recalling Firm
Cook Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
International Distribution to: Korea only
Code Information
UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated