Cook recalls Coons Interventional Wire Guides with potential packaging seal breaches that could compromise sterility. Affected units have specific part numbers and expiration dates.
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 Coons Interventional Wire Guides due to possible breaches in the packaging seal. This could mean the devices are no longer sterile, which is dangerous for medical procedures.
The packaging seal may be completely breached, which could compromise the sterility of the devices. If the devices are not sterile, they could cause infections during medical procedures.
Healthcare professionals using these devices for medical procedures are most at risk. Patients receiving procedures with compromised sterile devices could face infection.
Check for part numbers THSF-35-145-COONS, THSF-38-145-COONS, THSF-35-180-COONS, or THSF-35-80-COONS with specific lot numbers and expiration dates listed in the recall notice.
Look for the part numbers and lot/expiry dates on the device packaging to confirm if it's affected.
Cook identified that some devices may have a complete breach of the chevron seal, which could compromise sterility.
The recall does not specify a remedy, so check the official notice for instructions on how to handle affected devices.
Yes, affected models include THSF-35-145-COONS, THSF-38-145-COONS, THSF-35-180-COONS, and THSF-35-80-COONS with specific lot numbers and expiration dates.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1828-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1828-2022 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.
