Medical device recalls Moderate risk

Cook Incorporated recalls Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

Recall date
October 8, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0347-2025
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 Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

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