Halyard CHRIST SUTURE KIT surgical needles coating defect recall
AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.
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 medical device recall. The source text describes a potential performance degradation (diminished performance and/or coating removal) but does not report any actual injuries, illnesses, or hospitalizations. The hazard is performance-related rather than a known safety threat, making it a moderate-severity precautionary recall.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CHRIST SUTURE KIT (Model No. ADVC800-03, UDI: 10809160450703, Lot Code: 1640852, expiration 2/4/2028) due to an issue with a raw material used to coat some surgical needles.
The coating problem may result in diminished performance and/or removal of silicone needle coating during surgical use. This could affect the intended function of the needles during procedures.
The affected product was distributed nationwide in Illinois and Louisiana. A total of 72 units are involved in this recall. Patients and healthcare providers who have these kits should contact AVID Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 72
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. ADVC800-03
- UDI: 10809160450703
- Lot Code: 1640852
- 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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