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Open, Classified

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

FDA Recall Z-0347-2025 · Posted 2024-11-08

Recalling FirmCook Incorporated
Recall StatusOpen, Classified
Product CodeDQX
Date Initiated2024-10-08
Product Quantity5,953 US; 2,528 OUS

Reason for Recall

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

Firm Action

On October 8, 2024, the firm notified affected consignees through Urgent Medical Device Recall letters. Customers were informed of the product issue and instructed to quarantine any affected product that remains unused. Product should be returned to Cook Medical. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091385APPROACH HYDRO ST WIRE GUIDE, MODEL HMWCook, Inc. · 2009-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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