Cook recalls Lead Clipper cardiac retrieval tool due to potential sterility compromise from packaging seal breach. Affected units have specific lot numbers; check your device for packaging integrity.
Sterility of device may be compromised due to breach of the chevron seal of the packaging
Cook is recalling its Lead Clipper tool used in cardiac procedures because the packaging seal might be broken, risking contamination. This could lead to infections if the device is used without proper sterility.
The packaging seal could be compromised, allowing contaminants to enter the device. This might lead to infections if the device is used without proper sterility during medical procedures.
Healthcare professionals using the Lead Clipper tool for cardiac lead retrieval are most at risk. Patients receiving this procedure may be affected if the device is used without proper sterility.
Check the device's lot number on the packaging. Affected units have specific lot numbers listed in the recall notice, including N172707 through N195738.
Look for the lot number on the packaging to determine if your device is affected. Affected units have specific lot numbers listed in the recall notice.
The device may not be sterile if the packaging seal is compromised, so it should not be used until the recall is addressed.
Check the lot number on the packaging. Affected units have specific lot numbers listed in the recall notice, including N172707 through N195738.
Check the device's lot number to see if it's affected. If it is, 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-2513-2023 — Cook Cook Hello, I own a Cook that is covered by recall Z-2513-2023 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.
