Surgical suture kit recalled for potential needle coating defects
AVID Medical is recalling Halyard CHRIST SUTURE KIT due to coating issues on surgical needles that may degrade during use. The defect could affect device performance in surgical procedures.
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: FDA Class II medical device with risk of impaired performance in surgical use, but no reported illnesses or injuries to date, placing it within the threshold for Score 3 per the rubric criteria.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CHRIST SUTURE KIT, a general procedure tray convenience kit used in surgical settings. The recall affects 72 units distributed nationwide to healthcare facilities in Illinois and Louisiana.
The recall was initiated due to a defect in the raw material used to coat surgical needles included in the kit. This coating defect may result in diminished performance of the needles and potential removal of the silicone coating during surgical use, which could compromise the intended function of the surgical instrument.
Healthcare providers and surgical facilities using this product should cease use and contact AVID Medical, Inc. for instructions regarding return or replacement. The affected lot is identified by Model No. ADVC800-03, UDI 10809160450703, Lot Code 1640852, with an expiration date of February 4, 2028. The FDA classified this as a Class II recall.
The recalled product
- Product
- Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Manufacturer
- AVID Medical, Inc.
- Hazard
- coating-defect
- device-performance-degradation
- surgical-complication
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
Distributed nationwide across the United States.
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