Recall Z-0499-2025 ยท DQX Wire, Guide, Catheter
Cook Incorporated
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
| Date | Nov 21, 2024 (initiated Oct 14, 2024) |
| Status | Open, Classified |
| Reason | Devices from the affected device lots have labels that state the incorrect expiration dates. |
| Root cause | Labeling Change Control |
| Action | An "URGENT: MEDICAL DEVICE RECALL" notification letter dated 10/14/24 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form |
| Quantity | 10 units |
| Distribution | International Distribution to: Korea only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171897 | Approach CTO Microwire Guide Cook Incorporated, Aug 21, 2017 |