Surgical Suture Pack Cardiovascular Kit Recalled for Needle Coating Defect
AVID Medical is recalling Halyard SUTURE PACK CABG cardiovascular surgical kits due to a raw material defect in the silicone coating of surgical needles. The coating may diminish or detach during use, potentially affecting suture performance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving surgical sutures used in critical cardiovascular procedures. Although no adverse events or illnesses have been reported, the coating defect presents a risk of diminished suture performance during coronary artery bypass surgery, which could affect patient outcomes. The theoretical risk of harm in a critical surgical procedure warrants a High severity rating.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kit due to a defect in the raw material coating of surgical needles included in the kit. These kits are used during coronary artery bypass graft procedures.
The silicone coating on the surgical needles may not perform as intended and could be diminished or removed during surgical use. This coating defect could affect the sutures' performance during the procedure.
The affected product was distributed nationwide with distribution in Illinois and Louisiana. The recall involves 60 units identified by Model No. SILV800-01, UDI 10809160450680, Lot Code 1642454, with an expiration date of February 4, 2028.
Healthcare facilities that received this lot should discontinue use and contact AVID Medical, Inc. regarding product disposition. Any adverse events or performance problems should be reported to the FDA.
The recalled product
- Product
- Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- coating-defect
- performance-degradation
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
Distributed nationwide across the United States.
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