AVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
AVID Medical is recalling 63 Halyard Total Joint 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level involving labeling errors that could result in temporary or medically reversible health consequences, such as an allergic reaction to latex.
Plain-English summary
AVID Medical, Inc. is recalling 63 kits of the Halyard TOTAL JOINT (Model/Catalog Number: MSBM036-03). The recall was initiated due to a labeling deficiency where the product packaging fails to identify that the statlock component contains natural rubber latex.
The affected units are identified by Lot Number 1632948 and UDI 10809160423578. These kits were distributed nationwide in the United States, specifically in the states of Mississippi and Texas.
Consumers and healthcare facilities should check their inventory for this specific lot number and UDI. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 63
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: 1632948 UDI: 10809160423578
Distribution
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