Cook recalls Approach CTO Micro Wire Guides with incorrect expiration dates on labels. Affected items include specific model numbers and production lots. Consumers should check labels for correct expiration dates.
Affected device lots have labels that state the incorrect expiration dates.
Cook is recalling certain Approach CTO Micro Wire Guides due to labels showing incorrect expiration dates. This could lead to using expired products, though the recall does not indicate immediate safety risks.
The labels on affected devices show incorrect expiration dates. This means the products might be expired, potentially leading to reduced effectiveness or safety issues if used beyond their intended shelf life.
Users of the Approach CTO Micro Wire Guides with specific model numbers and production lots listed in the recall. Medical professionals who use these devices are most at risk.
Check the label for the model number (CMW-14-190-12G, CMW-14-190-18G, etc.) and production lot numbers listed in the recall. The product includes specific reference part numbers and production lots.
Verify the expiration date on the label matches the correct date for the specific model and lot number.
The recall is due to labels showing incorrect expiration dates, which could mean the products are expired and less effective.
Check the label for model numbers like CMW-14-190-12G or CMW-14-300-18G and production lots listed in the recall details.
No, the recall does not require stopping use; checking expiration dates is sufficient.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0346-2025 — Cook Cook Hello, I own a Cook that is covered by recall Z-0346-2025 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.