Medical device recalls Moderate risk

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

Recall date
October 14, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0499-2025
FDA classification
Class II
Brand / firm
Cook Incorporated
Sold / distributed
International Distribution to: Korea only

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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