Innovative Tomography recalls certain sterile coaxial needles that may not have been properly sterilized. These medical devices are not distributed in the US and pose a risk of infection if used.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Innovative Tomography is recalling specific sterile coaxial needles that may not have been adequately sterilized. Using these needles could lead to infection if they are not properly sterilized, which is a serious medical risk.
The needles are labeled as sterile but may not have been properly sterilized. This means they could contain harmful bacteria or other contaminants that could cause infections when used in medical procedures.
Medical professionals who use these needles for procedures in the EU are affected. Patients using these needles in procedures could be at risk of infection.
Check for the article numbers KIR 23/05 through KIR 17/15:45 on the needle packaging. These needles are not distributed in the US, so US users are not affected.
Immediately stop using any recalled needles as they may not be sterile and could cause infections.
No, these needles are not distributed within the US.
Using these needles could lead to infection if they are not properly sterilized.
Check the article numbers on the packaging: KIR 23/05 through KIR 17/15:45. These needles are not distributed in the US.
We’ve drafted a message you can send Innovative Tomography to request your refund or repair — edit it as you like.
Subject: Recall Z-2163-2021 — Innovative Tomography Innovative Tomography Hello, I own a Innovative Tomography that is covered by recall Z-2163-2021 from Innovative Tomography. 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.
