FDA Medical Device Recalls (openFDA)
Cook Incorporated: Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Recall number
- Z-0499-2025
- Recalling firm
- Cook Incorporated
- Product
- Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Status
- Open, Classified
- Initiated
- 2024-10-14
- Posted
- 2024-11-21
- Terminated
- not on file
- 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 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 (FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com. 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.
- Quantity
- 10 units
- Distribution
- International Distribution to: Korea only
- Lot, serial or model codes
- UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
- 510(k) numbers
- K171897
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28