FDA-Device2026-09-02Class IIMISBRANDING
Halyard DAVINCI TRUCUSTOM Foley catheter bundle recalled for undisclosed latex in Statlock component
What this means
Halyard's DAVINCI TRUCUSTOM medical kit contains a Statlock component made with natural rubber latex, but the product labeling does not warn of this. People with latex allergies could have a serious reaction if exposed during use.
- If you have this kit (Lot Number 1634391), do not use it.
- Check the labeling on your DAVINCI TRUCUSTOM bundle for the lot number.
- Contact Halyard or your healthcare provider for a replacement kit without latex or with proper labeling.
The agency's original wording
Hazard
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MS, TX.
Affected count
45 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3005-2026More AVID Medical recalls
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- FDA-Device2026-09-23AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
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