Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

FISTULA ON-OFF KIT. Medical convenience kit Recalled by Avid Medical, Inc. Due to Medical convenience kits are being recalled due to...

Date: April 9, 2021
Company: Avid Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Avid Medical, Inc. directly.

Affected Products

FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

Quantity: 720 kits

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Avid Medical, Inc.

Avid Medical, Inc. has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report