Recall Z-0347-2025— Cook Incorporated

Name: FDA recall Z-0347-2025
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: K091385. Product: Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST. 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

K091385 — APPROACH HYDRO ST WIRE GUIDE, MODEL HMWCook, Inc.·cleared 2009-08-07

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

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.