Recall Z-0347-2025 ยท DQX Wire, Guide, Catheter
Cook Incorporated
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
| Date | Nov 8, 2024 (initiated Oct 8, 2024) |
| Status | Open, Classified |
| Reason | Affected device lots have labels that state the incorrect expiration dates. |
| Root cause | Labeling Change Control |
| 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 |
| Quantity | 5,953 US; 2,528 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091385 | APPROACH HYDRO ST WIRE GUIDE, MODEL HMW Cook, Inc., Aug 7, 2009 |