Cook recalls Approach CTO Micro Wire Guide with incorrect expiration dates on labels. Affected lots may have safety risks if used beyond expiration.
Devices from the affected device lots have labels that state the incorrect expiration dates.
Cook is recalling its Approach CTO Micro Wire Guide due to labels with incorrect expiration dates. This could lead to using the product after it has expired, potentially causing safety issues.
The product has labels with incorrect expiration dates, which means it might be used after the expiration date. This could lead to reduced effectiveness or safety issues if the product is no longer stable or safe after expiration.
Users of the Approach CTO Micro Wire Guide who purchased it with the affected lot numbers are likely affected. Medical professionals using the product for procedures are at higher risk if the expiration date is incorrect.
Check the label for the product name 'Approach CTO Micro Wire Guide' and lot numbers NS15635381, NS15618280, NS15466311, NS15212224, or NS14992020. The product also has a unique identifier UDI-DI: 00827002507890.
Look for the expiration date on the product label to ensure it matches the correct date.
The product has labels with incorrect expiration dates, which could lead to using it after it has expired.
Check the expiration date on the label. If it's incorrect, contact Cook for guidance.
Check the lot numbers: NS15635381, NS15618280, NS15466311, NS15212224, or NS14992020.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2025 — Cook Cook Hello, I own a Cook that is covered by recall Z-0499-2025 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
