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AVID Medical, Inc. recalls Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number
Recalled September 2, 2026 · FDA recall Z-3005-2026 · AVID Medical
Hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. · FDA Class II
Units
45 kits
Sold at
US Nationwide distribution in the states of MS, TX.
Description
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Product
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Manufacturer(s)
AVID Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →