Cook recalls Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches. Affected lots include 9706696, 9707671, 9709328, 9711384, 9718538. Consumers should check UDIs for affected units.
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 contamination. This could lead to infections or other complications during medical procedures. The recall affects specific lot numbers and units with unique identifiers.
The packaging pouches for Torcon NB Advantage Catheters may have undersealed chevrons, which could compromise the sterility of the product. If the product is not sterile, it may cause infections or other complications during medical procedures.
Physicians using these catheters in vascular procedures are most at risk. Patients receiving the catheters during procedures may be affected if the contaminated product is used.
Check the lot numbers: 9706696, 9707671, 9709328, 9711384, 9718538. Look for the unique device identifier (UDI) codes listed in the recall notice.
Compare your product's lot number to the affected lots listed: 9706696, 9707671, 9709328, 9711384, 9718538.
Check the product for the unique device identifier (UDI) codes provided in the recall notice.
The recall indicates a potential sterility issue, but the product is safe for use if the packaging is intact and not affected by the undersealed chevron issue.
Check the lot number on your catheter against the affected lots: 9706696, 9707671, 9709328, 9711384, 9718538.
The recall does not specify a remedy, so contact Cook directly for guidance on handling affected units.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0468-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0468-2020 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.
