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

Recall Insight

This FDA Devices action (record #Z-1785-2021) was formally reported on June 16, 2021, with the manufacturer initiating the action on April 9, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Avid Medical, Inc. is listed as the recalling firm, operating out of Toano, VA. Federal records indicate 720 kits units are affected.

The documented reason for this recall is: 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 penicilli… Distribution data in the federal record shows the product reached: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.