Mivi Neuroscience recalls Super 90 Guide Catheters and Mi-Axus 8F Catheters due to potential nonsterility from pouch seal defects. Affected products include specific model numbers and expiration dates.
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Mivi Neuroscience is recalling Super 90 Guide Catheters and Mi-Axus 8F Catheters because the pouch seal might not be sterile, which could lead to infections during medical procedures. This recall affects specific model numbers and expiration dates listed in the notice.
The pouch seal defect could allow contamination, making the catheters nonsterile. This poses a risk of infection during medical procedures if the catheters are used without proper sterility.
Healthcare professionals and patients using these catheters for medical procedures. Those with the specific model numbers and expiration dates listed in the recall are most at risk.
Check for model numbers like MIA-9080S (80 cm), MIA-9090S (90 cm), or MIA-9095S (95 cm) with expiration dates listed in the recall notice.
Look for model numbers and expiration dates on the catheter packaging or label to confirm if it's affected.
The recall is due to a potential defect in the pouch seal that could lead to nonsterility, increasing infection risk during medical procedures.
Affected models include MIA-9080S (80 cm), MIA-9090S (90 cm), MIA-9095S (95 cm), and their extended versions with specific expiration dates listed in the recall.
The recall does not require immediate discontinuation; check the model and expiration dates to determine if your product is affected.
We’ve drafted a message you can send Mivi Neuroscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2441-2021 — Mivi Neuroscience Mivi Neuroscience Hello, I own a Mivi Neuroscience that is covered by recall Z-2441-2021 from Mivi Neuroscience. 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.
