AVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Error
AVID Medical, Inc. is recalling 78 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
What this means for you
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 indicates a moderate risk. The hazard is a labeling deficiency regarding natural rubber latex, a known allergen, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
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 are identified by Lot Number 1649979 and UDI 10809160457887. These kits were distributed nationwide in the United States, specifically in the states of Mississippi and Texas.
Consumers and healthcare providers should check their inventory for the specific lot number and UDI listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with the recall 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: 1649979 UDI: 10809160457887
Distribution
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