Cook recalls Amplatz extra Stiff Wire Guides with potential packaging seal breaches that could compromise sterility. Affected units have specific part numbers and lot dates. Consumers should check their device details.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Cook is recalling certain Amplatz extra Stiff Wire Guides due to possible packaging seal breaches that might compromise sterility. This means the devices could not be properly sterilized, posing a risk of infection during medical procedures.
The packaging seal may be completely breached, which could mean the devices are not properly sterilized. If used without proper sterilization, this could lead to infections during medical procedures.
Medical professionals using the Amplatz extra Stiff Wire Guides for procedures. Those with the specific part numbers and lot dates listed in the recall are most at risk.
Check for the part numbers THSF-35-145-AES-SGH (GPN G06801) or THSF-38-80-AES-SGH (GPN G06874). Look for the lot numbers 14767453 (expiration 02-06-2027) or 14802152 (expiration 20-06-2027).
Identify your device using the part numbers and lot numbers listed in the recall notice.
Cook identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
The affected part numbers are THSF-35-145-AES-SGH (GPN G06801) and THSF-38-80-AES-SGH (GPN G06874).
Check for the lot numbers 14767453 (expiration 02-06-2027) or 14802152 (expiration 20-06-2027) on your device.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1824-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1824-2022 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.
