AVID Medical, Inc. recalls Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE
See all recalls from AVID Medical, Inc. →Recalled Product
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Hazard / Issue
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: Lot Number: 1634391 UDI: 10809160439708
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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