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 device recall Z-0347-2025 · posted 2024-11-08 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- Reason for recall
- Affected device lots have labels that state the incorrect expiration dates.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DQX
- Quantity affected
- 5,953 US; 2,528 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2024-10-08
- Date posted
- 2024-11-08
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APPROACH HYDRO ST WIRE GUIDE, MODEL HMW (K091385) | Cook, Inc. | 2009-08-07 |