Device recall

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

FDA recall source

Recall number

Z-3005-2026

Event id

99527

Status

Ongoing

FDA classification

Class II

Recalling firm

AVID Medical, Inc.

Report date

Sep 2, 2026

Posted

Aug 21, 2026

Initiated

Jul 9, 2026

Center classification date

Aug 21, 2026

Product code

LRO

Device type

General Surgery Tray

Reason

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

Root cause

Labeling Change Control

Quantity

45 kits

Code info

Lot Code: Lot Number: 1634391 UDI: 10809160439708

Distribution

US Nationwide distribution in the states of MS, TX.

Voluntary or mandated

Voluntary: Firm initiated

Location

Toano, VA, United States