Use cautionMedical device recall · FDA · Published April 9, 2021
Avid Medical FISTULA ON-OFF Kit Recall: Risk of Aspergillus Contamination
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.
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Contact the company
📍Recalling firmAvid Medical, Inc.9000 Westmont Dr · Toano, VA 23168-9351
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/62800-avid-medical-fistula-on-off-kit-recall-risk-of-aspergillus.
“Avid Medical FISTULA ON-OFF Kit Recall: Risk of Aspergillus Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62800-avid-medical-fistula-on-off-kit-recall-risk-of-aspergillus. Based on FDA recall #Z-1785-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1785-2021%22&limit=1).
The FDA announced on April 9, 2021, that Avid Medical is recalling the FISTULA ON-OFF KIT due to potential contamination from Aspergillus penicillioides. The agency stated the recall involves medical convenience kits with a breach in package integrity.
How to tell if you have it
Brand: Avid Medical
Product: FISTULA ON-OFF KIT
Part Number: MMTN020
UPC: 20809160223489
Lot Number: 1351695 (Expiration Date: 10/31/2021)
Distribution: US nationwide to TX, AZ, IL, MS, LA, MO, and TN
The hazard
The kits are being recalled because the BD ChloraPrep 3mL applicator may grow Aspergillus penicillioides under certain circumstances, resulting in a breach of package integrity. This breach may contaminate other components in the AVID Medical kits.
Context
GovInfoNow's records show Avid Medical has 24 other recalls on record since June 22, 2017. Recent brand recalls include a Haylard 18G Epi Tray recall for sterility risk and a DAVINCI LAP/GYN recall for potential lubricant contamination, both announced on August 10, 2026. Other recent recalls of similar products include Medline Convenience Kits Recall: Fungal Contamination Risk (August 11, 2026) and Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026).
How to tell if you have this one
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.
Brand
Avid Medical
Product
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Recall number
Product, codes & lots
Quantity
Z-1784-2021
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04; Part Number: LAKC001-04; Package GTIN: 20809160261016; Lot Number: 1404809 (Expiration Date: 08/01/2021) and 1408337 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160293130; Lot Number: 1427628 (Expiration Date: 09/01/2021) Part Number: LAKC001-04; Package GTIN: 20809160313005; Lot number: 1427629 (Expiration Date: 09/01/2021), 1432814 (Expiration Date: 11/30/2021), and 1436046 (Expiration Date: 11/30/2021)
130 kits
Z-1785-2021
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.; Part Number: MMTN020; Package GTIN: 20809160223489; Lot Number: 1351695 (Expiration Date: 10/31/2021)
720 kits
Z-1786-2021
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03; Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)
160 kits
Z-1787-2021
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.; Part Number:VMED004-03; Package GTIN: 20809160238247; Lot Number: 1409970 (Expiration Date: 04/26/2022), 1412734 (Expiration Date: 10/01/2021), 1413146 (Expiration Date: 10/01/2021), and 1413395 (Expiration Date: 04/25/2022)
560 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the part number MMTN020 and lot number 1351695 on the kit packaging.
Contact Manufacturer
Reach out to Avid Medical for guidance on next steps if you have the recalled kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Illinois, Louisiana, Mississippi, Missouri, Tennessee, Texas.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1785-2021 (April 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1785-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.