Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches. Affected units have specific lot numbers and UDIs. Consumers should contact Cook for details.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Cook is recalling Torcon NB Advantage Catheters because the packaging pouches might not seal properly, risking contamination. This could lead to infections if the catheters are used without proper sterility.
The catheters' packaging pouches may have an undersealed chevron, which could compromise sterility. If the pouch isn't sealed properly, the catheters might become contaminated during use, increasing infection risk.
Physicians using these catheters in vascular procedures are most at risk. The recall affects specific lot numbers and units sold with unique identifiers.
Check for lot numbers NS9715223 or NS9718545 on the packaging. Also look for unique identifiers starting with (01)00827002060395.
Look for lot numbers NS9715223 or NS9718545 on the packaging or unique identifiers starting with (01)00827002060395.
The packaging pouches may have an undersealed chevron, which could compromise sterility and lead to contamination.
Check for the specific lot numbers or unique identifiers listed. Contact Cook directly for further instructions.
There is a potential risk of contamination if the packaging pouches are not sealed properly, which 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-0438-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0438-2020 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.
