Cook recalls Torcon NB Advantage Catheters with undersealed packaging pouches that may compromise sterility. Affected lot numbers include 9696901, 9700384, 9701377, 9708543, 9709229. 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 that may have undersealed packaging pouches, risking contamination. This could lead to infections if used in medical procedures. Affected units have specific lot numbers listed in the recall notice.
The catheters' packaging pouches may have an undersealed chevron, which could compromise sterility. If the pouch is not properly sealed, the catheters might become contaminated during storage or handling. This contamination could lead to infections during medical procedures.
Physicians using Torcon NB Advantage Catheters for vascular procedures are most at risk. Patients receiving these catheters could face infection if the contaminated product is used.
Check the lot numbers: 9696901, 9700384, 9701377, 9708543, 9709229. The product is used in vascular procedures by trained physicians for coronary and peripheral systems.
Look for lot numbers 9696901, 9700384, 9701377, 9708543, or 9709229 on the packaging.
The packaging pouches may have an undersealed chevron, which could compromise sterility and lead to contamination.
Check the lot numbers listed in the recall notice. If you have an affected lot number, contact Cook for further instructions.
The recall addresses potential contamination risk, not direct injury. The hazard is low risk as it relates to sterility, not immediate harm.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0451-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0451-2020 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.
