Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging. Affected units may have contaminated catheters that could cause infection during medical procedures.
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 during medical procedures if the catheters are used without proper sterility.
The catheters' packaging pouches may have an undersealed chevron, which could allow contaminants to enter the sterile product. This risk exists if the packaging is not properly sealed during manufacturing or handling.
Physicians using these catheters for vascular procedures are most at risk. Patients undergoing procedures with these catheters could face infection if sterility is compromised.
Check for lot number NS9933578 or UDI (01)00827002127838(17)220812(10)NS9933578 on the packaging. These catheters were sold for use in vascular procedures by physicians trained in angiographic techniques.
Look for lot number NS9933578 or UDI (01)00827002127838(17)220812(10)NS9933578 on the packaging.
The packaging pouches may have an undersealed chevron, which could allow contaminants to enter the sterile product.
Check the packaging for lot number NS9933578 or UDI (01)00827002127838(17)220812(10)NS9933578. If you have the lot number, contact Cook for further instructions.
This recall addresses potential sterility compromise, which could lead to infection during medical procedures if the catheters are not properly sterile.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0483-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0483-2020 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.
