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Medical Device

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

Recall date: 2026-09-02 · Source: FDA_DEVICE
Brand / Firm
AVID Medical, Inc.
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.
Units affected
45 kits
Description
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
View official recall notice →