| Recall Number | Z-3005-2026 |
|---|---|
| Recalling Firm | AVID Medical, Inc. |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | US Nationwide distribution in the states of MS, TX. |
| Status | Ongoing |
| Device Class | N/A |
| Device Name | N/A |
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Lot Code: Lot Number: 1634391 UDI: 10809160439708