Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches. Affected lot numbers include 9700004, 9703928, and NS9703929. Consumers should check packaging for UDIs to confirm eligibility.
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 their packaging pouches may have undersealed chevrons, risking loss of sterility. This could lead to infections if the catheters are used without proper sterility. The recall affects specific lot numbers and requires checking packaging for unique identifiers.
Undersealed chevrons in the packaging pouches could compromise sterility. If the catheters are used without proper sterility, infections may occur during medical procedures. This is a packaging issue, not a defect in the catheters themselves.
Physicians using Torcon NB Advantage Catheters for vascular procedures are most at risk. The recall applies to specific lot numbers sold with unique identifiers.
Check the packaging for lot numbers 9700004, 9703928, or NS9703929. Look for unique identifiers (UDIs) starting with (01)00827002082014.
Look for lot numbers 9700004, 9703928, or NS9703929 on the packaging.
The packaging pouches may have undersealed chevrons, which could compromise sterility and lead to infections if used improperly.
Check the packaging for lot numbers 9700004, 9703928, or NS9703929. If you have these, contact Cook for instructions.
The recall is for potential sterility issues, which could lead to infections if the catheters are used without proper sterility. However, the risk is low if the catheters are handled correctly.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0452-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0452-2020 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.
