Cook recalls Fixed Core Wire Guides with potential packaging seal breaches that could compromise sterility. Affected units include specific part numbers and expiration dates. Consumers should check their product details and contact Cook for guidance.
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 Fixed Core Wire Guides that may have packaging seals that are completely breached. This could mean the medical devices are no longer sterile, which is dangerous during surgery.
The packaging seal may be completely breached, which could allow contamination. This means the devices might not be sterile when used in surgery, increasing infection risk for patients.
Medical professionals using these devices for surgery are most at risk. Patients undergoing procedures with compromised sterile devices could face infections.
Check for part numbers THSCF-25-180-3 G02165 or TSCF-25-80-3 G00476. The expiration dates listed are June 2027 for specific lots.
Identify your device using the part numbers or expiration dates listed in the recall notice.
Cook Medical identified that some devices may have a complete breach of the chevron seal in the packaging, which could compromise sterility.
Check your device's part numbers and expiration dates against the recall list. Contact Cook for further guidance.
The recall addresses potential sterility issues, not direct injury risks. However, using non-sterile devices during surgery could lead to infections.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1832-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1832-2022 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.
