Z-0499-2025Class II

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Name: Z-0499-2025 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Creator: Cook Incorporated
Published: 2024-10-14
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2024-10-14 / Open, Classified / root cause: labeling and UDI

FDA source

Cook Incorporated began a recall of Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 on 2024-10-14. FDA classified it as Class II and gives the reason as "Devices from the affected device lots have labels that state the incorrect expiration dates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0499-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-14
Posted: 2024-11-21
Recalling firm: Cook Incorporated
Product: Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Product code: DQX Wire, Guide, Catheter
Reason for recall: Devices from the affected device lots have labels that state the incorrect expiration dates.
Root cause tag: labeling and UDI
FDA 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 ([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.
Quantity in commerce: 10 units
Distribution: International Distribution to: Korea only
Product codes and lots: UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0499-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0499-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-21

Product code DQX

K171897Class IIApproach CTO Microwire GuideCook Incorporated / cleared 2017-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)