Class II

Medical Device Recall: 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

Cook Incorporated · October 8, 2024

Reason for Recall

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

Product Description

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

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

2,005 US; 1,145 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0346-2025

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.