Cook recalls Movable Core Wire Guide (Tefcor) devices with specific part numbers due to potential packaging seal breach, risking compromised sterility. Affected units may not be safe for medical use.
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 Movable Core Wire Guide (Tefcor) devices with part number TMT-35-145 G01677 because the packaging seal might be broken, which could mean the devices aren't sterile anymore. This is serious because medical devices must be sterile to avoid infections during surgery.
The packaging seal might be completely broken, meaning the devices could be contaminated. Medical devices must be sterile to prevent infections during surgery, so a compromised seal makes them unsafe for use.
Medical professionals using these devices for surgery or procedures are most at risk. Patients could get infected if the devices aren't sterile.
Check for part number TMT-35-145 G01677 on the device. The lot number starts with 00827002016774 and expires on June 22, 2027.
Immediately stop using the affected Movable Core Wire Guide (Tefcor) devices as they may not be sterile.
Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
Look for part number TMT-35-145 G01677 on the device. The lot number starts with 00827002016774 and expires on June 22, 2027.
Immediately stop using the device and contact Cook 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-1847-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1847-2022 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.
