Innovative Tomography recalls certain sterile coaxial interventional needles due to potential inadequate sterilization. Affected models include KIM 22/05 to KIM 14/20T with specific lot numbers. Consumers should check their product details and contact the manufacturer for guidance.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Innovative Tomography is recalling specific models of sterile coaxial interventional needles because they may not have been properly sterilized. This could lead to infections if the needles are used in medical procedures. Affected items have unique model numbers and lot numbers listed in the recall notice.
The needles are labeled as sterile but may not have been adequately sterilized during manufacturing. If used in medical procedures without proper sterilization, this could lead to infections or other complications.
Medical professionals and hospitals that use these needles for procedures are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check the product label for model numbers starting with KIM (e.g., KIM 22/05, KIM 22/07) and the specific lot numbers listed in the recall notice. The needles come in various lengths and diameters.
Look for the model number (e.g., KIM 22/05) and lot number on the product label to confirm if it is affected.
The needles may not have been adequately sterilized, so they are not safe for medical use. Affected models should be checked and discarded or returned.
Contact Innovative Tomography directly to confirm if your specific model and lot number are affected and follow their instructions.
Check the product label for model numbers starting with KIM (e.g., KIM 22/05) and the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Innovative Tomography to request your refund or repair — edit it as you like.
Subject: Recall Z-2162-2021 — Innovative Tomography Innovative Tomography Hello, I own a Innovative Tomography that is covered by recall Z-2162-2021 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.
