AVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
AVID Medical is recalling 120 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: This is a labeling error regarding a common allergen (latex) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AVID Medical, Inc. is recalling 120 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 products are identified by Lot Number 1662335 and UDI 10809160457887. These kits were distributed nationwide in the United States, specifically in the states of Mississippi and Texas.
Consumers and healthcare facilities should stop using these kits and contact AVID Medical, Inc. for instructions on return or replacement. Individuals with a known latex allergy should be particularly cautious and verify the contents of any medical kits they possess.
The recalled product
- Product
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 120
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: 1662335 UDI: 10809160457887
Distribution
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