Cook recalls Newton Wire Guides with specific part numbers due to potential packaging seal breaches that could compromise sterility. Affected devices may not be sterile, risking infection during medical procedures.
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 Newton Wire Guides because the packaging seal might be broken, which could mean the devices aren't sterile. This is dangerous for medical procedures since unsterile devices can cause infections.
The packaging seal could be completely breached, meaning the devices might not be sterile. If the devices aren't sterile, they could cause infections during medical procedures.
Medical professionals using Cook's Newton Wire Guides for procedures may be affected. Patients undergoing surgery with these devices face the highest risk of infection.
Check for part numbers TSFNA-35-145 G00701 or TSFNA-35-145-3 G00561. Devices sold with expiration dates June 2027 or July 2027 are affected.
Look for part numbers TSFNA-35-145 G00701 or TSFNA-35-145-3 G00561 on the device packaging.
Cook identified that some devices may have a complete breach of the chevron seal, which could compromise sterility.
The recall record does not specify a remedy, so contact Cook directly for guidance.
Yes, affected devices have expiration dates of June 2027 or July 2027.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1836-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
