Recall Z-0346-2025— Cook Incorporated

Name: FDA recall Z-0346-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-08

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2024-10-08. It names one FDA 510(k) clearance: K171897. Product: 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. Reason: Affected device lots have labels that state the incorrect expiration dates..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2024-10-08
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, 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

Reason for recall

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

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