Class II

Medical Device Recall: Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

Cook Incorporated · October 8, 2024

Reason for Recall

Affected device lots have labels that state the incorrect expiration dates.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

5,953 US; 2,528 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0347-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.