United StatesHalyard DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK (catalog SAMM064-27) and Halyard TOTAL JOINT (catalog MSBM036-03) kits, identified by the listed lot numbers and UDIs, distributed in Mississippi and Texas, are affected. They were recalled because the kit labeling fails to identify that the StatLock component contains natural rubber latex.
What's being recalled
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Recalling firm: AVID Medical, Inc., Toano, VA, United States.
How to identify it
Lot Code: Lot Number: 1634391 UDI: 10809160439708 Lot Code: Lot Number: 1632948 UDI: 10809160423578 Lot Code: Lot Number: 1649979 UDI: 10809160457887 Lot Code: Lot Number: 1654575 UDI: 10809160457887 Lot Code: Lot Number: 1662335 UDI: 10809160457887 Lot Code: Lot Number: 1673233 UDI: 10809160457887 Lot Code: Lot Number: 1649519 UDI: 10809160457887
The hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of MS, TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)