FDA recall Z-0499-2025

Product

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

Reason for recall

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

Distribution

International Distribution to: Korea only

Key facts

Status

Ongoing

Initiation date

2024-10-14

Report date

2024-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2025