Halyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
AVID Medical is recalling 45 Halyard DAVINCI TRUCUSTOM Foley catheter kits because the labeling fails to identify that the statlock component contains natural rubber latex.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling for a common allergen (natural rubber latex) on a medical device, which fits the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling 45 kits of the Halyard DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK (Model/Catalog Number: SAMM064-27). The recall is due to a labeling deficiency where the product packaging fails to identify that the statlock component contains natural rubber latex.
The affected products are identified by Lot Number 1634391 and UDI 10809160439708. These kits were distributed nationwide in the United States, specifically in the states of Mississippi and Texas.
Individuals with a known latex allergy should avoid using these products. Healthcare facilities and consumers should check their inventory for the specific lot number and model number listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot Number: 1634391 UDI: 10809160439708
Distribution
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