Halyard Total Joint Kits Recalled for Latex Labeling Deficiency
AVID Medical is recalling 78 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, but the source text describes a labeling deficiency regarding latex content without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
AVID Medical, Inc. is recalling 78 kits of the Halyard TOTAL JOINT (Model/Catalog Number: MSBM036-03). 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 were distributed nationwide in the United States, specifically in the states of Mississippi and Texas. The specific lot number is 1649519 and the UDI is 10809160457887.
Consumers and healthcare providers should check their inventory for this specific model and lot number. 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
- 78
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: 1649519 UDI: 10809160457887
Distribution
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