Recall Z-0499-2025— Cook Incorporated

Name: FDA recall Z-0499-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-14

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2024-10-14. It names one FDA 510(k) clearance: K171897. Product: Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789. Reason: Devices from the affected device lots have labels that state the incorrect expiration dates..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2024-10-14
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K171897 — Approach CTO Microwire GuideCook Incorporated·cleared 2017-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.