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 and contact Cook for guidance.
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 in medical procedures. The recall affects specific lot numbers and unique identifiers.
The catheters' packaging pouches may have an undersealed chevron, which could compromise sterility. If the packaging is not properly sealed, the catheters might become contaminated during use, increasing infection risk.
Physicians using Torcon NB Advantage Catheters for vascular procedures are most at risk. The recall applies to specific lot numbers and unique identifiers from the product's packaging.
Check the lot number on the packaging (9710345) and the unique device identifier (UDI) code (01)00827002107502(1.7)220515(10)9710345. The product is intended for use in vascular procedures by trained medical professionals.
Look for the lot number 9710345 and UDI code (01)00827002107502(17)220515(10)9710345 on the packaging.
The packaging pouches may have an undersealed chevron, which could compromise sterility and lead to contamination.
Check the lot number and UDI code on the packaging. If it matches the recalled details, contact Cook for guidance.
The recall indicates a potential sterility risk, so it's recommended to check the product details before use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0471-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0471-2020 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.
