Halyard SUTURE PACK CABG Cardiovascular Kit Needle Coating Issue
AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential performance defect in surgical needles, not a high-risk pathogen or structural failure, making it a moderate-severity precautionary recall.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kit (Model No. SILV800-01, UDI: 10809160450680, Lot 1642454, Exp. 2/4/2028) due to an issue with a raw material used to coat some of the surgical needles included in the kit.
The coating defect may result in diminished performance of the needles and/or removal of some silicone needle coating during surgical use. This could compromise the effectiveness of the sutures during cardiovascular bypass procedures.
The affected kits were distributed nationwide in Illinois and Louisiana. Patients and healthcare facilities that have received or used these kits should contact AVID Medical, Inc. for further guidance on the recall and any necessary follow-up actions.
The recalled product
- Product
- Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 60
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 (4)
- Model No. SILV800-01
- UDI: 10809160450680
- Lot Code: Lot: 1642454
- Exp: 2/4/2028.
Distribution
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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