Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units have specific lot numbers and UDI codes. Consumers should check their product details to determine if recalled.
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 may 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 during use. This means the catheters might not be sterile when used, increasing infection risk.
Physicians using Torcon NB Advantage Catheters for vascular procedures are likely affected. Those with the specific lot numbers or UDI codes from the recall list are at risk.
Check for lot number 9716495 or UDI code (01)00827002097575(17)220517(10)9716495 on the packaging. These catheters are intended for use in vascular procedures by trained physicians.
Look for the lot number 9716495 or UDI code (01)00827002097575(17)220517(10)9716495 on the packaging.
The packaging pouches may have an undersealed chevron, which could compromise sterility during use.
Check the product details for the lot number or UDI code to see if it's affected. If it is, contact Cook for further instructions.
The recall addresses potential sterility compromise, which could lead to infections. There is no mention of immediate injury risks in normal use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0459-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0459-2020 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.