Cook recalls certain Fixed Core Wire Guides due to potential packaging seal breach, risking device sterility. Affected items include 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 specific Fixed Core Wire Guides that may have a packaging seal breach, which could compromise the sterility of the devices. This means the products might not be sterile when used, posing a risk during medical procedures.
The packaging seal may be completely breached, meaning the devices might not be sterile when they are used. This could lead to infections during medical procedures if the devices are not properly sterilized.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices could face infection risks if the devices are not sterile.
Check for part numbers like C-SF-18-30 G02261, C-SF-25-40 G01937, TSF-18-260 G00590, and other listed models. The expiration dates range from June 2027 to July 2027.
Look for the part numbers and expiration dates listed in the recall notice to confirm if your device is affected.
Cook identified that some devices may have a complete breach of the chevron seal in the packaging, which could compromise sterility.
Check for specific part numbers and expiration dates listed in the recall notice, such as C-SF-18-30 G02261 or TSF-18-260 G00590 with expiration dates from June 2027 to July 2027.
The recall notice does not specify a remedy, so you should contact Cook directly for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1834-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1834-2022 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.
