Recall Z-0346-2025 ยท DQX Wire, Guide, Catheter
Cook Incorporated
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
| 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 | 2,005 US; 1,145 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171897 | Approach CTO Microwire Guide Cook Incorporated, Aug 21, 2017 |