Avid Medical recalls FISTULA ON-OFF Kit (Part MMTN020) due to potential Aspergillus contamination from package breaches. Affected kits may need replacement to prevent infection risks.
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Avid Medical is recalling its FISTULA ON-OFF Kit (Part Number MMTN020) because a component could breach its packaging, potentially growing Aspergillus penicillioides. This contamination risk could affect other kit components and lead to infection if used.
The BD ChloraPrep 3mL applicator in the kit may develop Aspergillus penicillioides if the packaging breaches. This mold can contaminate other kit components, increasing infection risk during medical procedures.
Patients using the FISTULA ON-OFF Kit for medical procedures are most at risk. The recall affects kits purchased between 2019 and 2021 with specific part numbers.
Check for the part number MMTN020 on the kit. Kits sold with the package GTIN 20809160223489 and lot number 1351695 (expired 10/31/2021) are affected.
Verify the part number MMTN020 and lot number 1351695 on the kit packaging.
Reach out to Avid Medical for guidance on next steps if you have the recalled kit.
The recall indicates a potential contamination risk, so it's recommended to stop using the kit until you confirm it's not affected.
Check for part number MMTN020 and lot number 1351695 (expired 10/31/2021) on the kit packaging.
Contact Avid Medical directly for instructions on how to handle the kit.
We’ve drafted a message you can send Avid Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1785-2021 — Avid Medical Avid Medical Hello, I own a Avid Medical that is covered by recall Z-1785-2021 from Avid Medical. 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.
