FDA recall Z-3005-2026

AVID Medical, Inc. · Class II · device

Product

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

Reason for recall

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Distribution

US Nationwide distribution in the states of MS, TX.

Key facts

Status
Ongoing
Initiation date
2026-07-09
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3005-2026