AVID Medical, Inc. recall Z-3005-2026 · FDA Recalls

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Class IIDeviceOngoing

AVID Medical, Inc.

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.

Details

Recall number: Z-3005-2026
Event ID: 99527
Recall initiated: Jul 9, 2026
Classified: Aug 21, 2026
Reported: Sep 2, 2026
Quantity: 45 kits
Distribution: US Nationwide distribution in the states of MS, TX.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Toano, VA, United States
Lot / code info: Lot Code: Lot Number: 1634391 UDI: 10809160439708