Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches. Affected lot numbers include 9696580 through NS9710401. Consumers should check product labels for specific lot numbers.
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 in medical procedures. The recall affects specific lot numbers listed in the notice.
The catheters' packaging pouches may have an undersealed chevron, which could compromise sterility during use. If the pouch isn't sealed properly, the catheters might become contaminated, increasing infection risk during medical procedures.
Physicians using these catheters in vascular procedures are most at risk. The recall applies to specific lot numbers produced between certain dates.
Check the product label for lot numbers: 9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, or NS9710401. The product is intended for use in vascular procedures by trained medical professionals.
Look for lot numbers on the packaging: 9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, or NS9710401.
The packaging pouches may have an undersealed chevron, which could compromise sterility during use, increasing infection risk.
Check the product label for lot numbers listed in the recall notice. If your catheter has one of the affected lot numbers, contact Cook for further instructions.
The recall indicates a potential risk of contamination, but the catheter is safe for use if it has a properly sealed packaging pouch.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0439-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0439-2020 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.
