Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK
- Recall date
- 2026-09-02
- Brand
- AVID Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Product description
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Affected products
Lot Code: Lot Number: 1634391 UDI: 10809160439708