Agency classClass IOur severity:Severe FDA (Devices)·Z-1785-2021·Announced 2021-06-16

Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination

Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This product received an FDA Class I designation, which under recall classification rules establishes a minimum score of 4 (Severe). Although the hazard is theoretical with no reported illnesses or injuries, Class I medical device recalls mandate a Severe minimum rating.

Plain-English summary

Avid Medical, Inc. is recalling 720 Fistula On-Off Kits (Part Number MMTN020, Lot Number 1351695 with expiration date 10/31/2021). These medical convenience kits contain a BD ChloraPrep 3mL applicator component.

The recall was issued because the applicator component may grow Aspergillus penicillioides under certain circumstances. If fungal growth occurs, it can breach the applicator's package integrity and potentially contaminate other components in the kit.

The affected kits were distributed nationwide to Texas, Arizona, Illinois, Mississippi, Louisiana, Missouri, and Tennessee.

This is an FDA Class I recall, the agency's most serious classification for medical devices.

The recalled product

Product: FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Manufacturer: Avid Medical, Inc.
Category: Medical Device — Medical Convenience Kit
Hazard: fungal-contamination
package-integrity-breach
Affected units: 720

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Part Number: MMTN020
Package GTIN: 20809160223489
Lot Number: 1351695 (Expiration Date: 10/31/2021)

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Avid Medical, Inc.

See all →

Moderate
Avid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
Moderate
Avid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
Moderate
AVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Moderate
Avid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
Moderate
AVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14

Same hazard · fungal contamination