FDAClass IINovember 27, 2024

Approach CTO Micro Wire Guide recall

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

Why was Approach CTO Micro Wire Guide recalled?

Devices from the affected device lots have labels that state the incorrect expiration dates.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020

Product
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Recalling firm
Cook Incorporated
Quantity
10 units
Distribution
International Distribution to: Korea only
Recall date
November 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls