Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Recall
- Recall Number
- Z-0499-2025
- Event Number
- 95582
- Firm
- Cook Incorporated
- FEI Number
- 1820334
- Product Code
- DQX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- October 14, 2024
- Posted
- November 21, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120
Description
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Devices from the affected device lots have labels that state the incorrect expiration dates.
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 within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Action being Taken by Cook Medical Cook Medical is removing affected products from the market. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500.
International Distribution to: Korea only
10 units