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 could compromise sterility during use. This risk is specific to medical procedures involving vascular systems and requires strict sterile conditions.
Physicians using these catheters in vascular procedures are most at risk. The recall affects specific lot numbers and UDI codes produced for medical use.
Check for lot number NS9906241 or UDI code (01)00827002068278(17)220801(10)NS9906241 on the packaging. These catheters are intended for use by physicians in vascular procedures.
Look for the lot number NS9906241 or UDI code (01)00827002068278(17)220801(10)NS9906241 on the packaging.
The packaging pouches may have an undersealed chevron, which could compromise sterility during use.
Check the product details for the lot number or UDI code. Contact Cook for further guidance if needed.
Yes, the potential compromise of sterility could lead to infections or complications if the catheters are used without proper sterility.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0446-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0446-2020 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.