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

Class II
Recalling firm
AVID Medical, Inc.
Reason for recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Affected products (lot / model / serial)
Lot Code: Lot Number: 1634391 UDI: 10809160439708
Units affected
45 kits
Distribution pattern
US Nationwide distribution in the states of MS, TX.
Firm location
Toano, VA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-3005-2026
Recall initiated
July 9, 2026
FDA classification date
August 21, 2026
FDA report date
September 2, 2026
FDA event ID
99527
Last updated on HTM Vibe
September 8, 2026
View on openFDA