FDA-Device2024-11-27Class II

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Cook Incorporated
Hazard

Devices from the affected device lots have labels that state the incorrect expiration dates.

Sold states
International Distribution to: Korea only
Affected count
10 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2025

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