Cook Incorporated recalls Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CM…

Recall date

October 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0346-2025

FDA classification

Class II

Brand / firm

Cook Incorporated

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

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, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G