Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Why it was recalled
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
Lot Code: Lot Number: 1634391 UDI: 10809160439708 — 45 kits
Record details
AVID Medical, Inc. — US Nationwide distribution in the states of MS, TX.