Cook recalls Movable Core Wire Guide (Tapered Tefcor) with possible packaging seal breach. Affected lots may have compromised sterility. Stop using if you own these specific model numbers.
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 a specific type of medical wire guide due to potential packaging seal breaches that could compromise sterility. This means the devices might not be sterile when used, which is dangerous for medical procedures.
The packaging seal may be completely breached, which could mean the devices are not sterile when opened. If used in medical procedures without proper sterility, this could lead to infections or other complications.
Medical professionals who use the Movable Core Wire Guide (Tapered Tefcor) in procedures. Those with the specific lot numbers listed in the recall are most at risk.
Check for the model number TCMTNA-35-145-3 G01678 on the device. Affected lots include 14808819 (expires 22-06-2027), 14821223 (expires 30-06-2027), and 14851713 (expires 21-07-2027).
Look for the model number TCMTNA-35-145-3 G01678 on the device packaging to confirm if it's affected.
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.
The recall record does not specify a remedy, so you should check the device packaging for the model number and lot dates to determine if it's affected.
Yes, affected lots include 14808819 (expires 22-06-2027), 14821223 (expires 30-06-2027), and 14851713 (expires 21-07-2027).
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1846-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1846-2022 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.
