TemporaryFDAOngoing
Can cause harm that is usually temporary.
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Check the device or its packaging for
Lot Code: Lot Number: 1634391 UDI: 10809160439708
- Why
- Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Distributed
- US Nationwide distribution in the states of MS, TX.
- Company
- AVID Medical, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3005-2026 · retrieved 21 August 2026
Read the official notice