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 or other complications if the catheters are used without proper sterility.
The catheters' packaging pouches may have an undersealed chevron, which can compromise sterility. If the packaging is not properly sealed, the catheters could become contaminated during use, increasing the risk of infection or other complications.
Physicians using Torcon NB Advantage Catheters in vascular procedures are most at risk. Patients receiving these catheters during procedures may also be affected if the sterility is compromised.
Check for lot number 9890919 or UDI code (01)00827002197060(17)220729(10)9890919 on the packaging. These catheters were sold for use in vascular procedures by physicians trained in angiographic techniques.
Look for lot number 9890919 or UDI code (01)00827002197060(17)220729(10)9890919 on the packaging.
The packaging pouches may have an undersealed chevron, which can compromise sterility, potentially leading to contamination.
Check for the specific lot number or UDI code on the packaging and contact Cook for guidance.
The recall is for potential sterility compromise, which could lead to infection, but the risk is not described as causing serious injury 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-0485-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0485-2020 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.
