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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard

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 Class 2 Device Recall Halyardsee related information
Date Initiated by FirmMarch 31, 2025
Date PostedMay 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1741-2025
Recall Event ID 96731
Product Classification General surgery tray - Product Code LRO
ProductHalyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Code Information Model No. ADVC800-03; UDI: 10809160450703; Lot Code: 1640852; Exp: 2/4/2028.
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
757-566-3510
Manufacturer Reason
for Recall		An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 3/31/25 was emailed to consignees. The notification indicates that this recall is due to Ethicon having recalled PDS II, PDS Plus, PROLENE, and ATHIBOND EXCEL sutures, which are components in the convenience kits being recalled by the recalling firm. Consignees are being instructed to discontinue use of the Johnson & Johnson Ethicon Sutures contained inside the recalled AVID kits identified in the recall notification and to add the provided labels to affected kits to ensure recalled sutures are discarded. Distributors are asked to forward the provided recall notification to their customers to which product was further distributed. Consignees are asked to return the provided response form via email. Questions regarding this recall event are to be directed to your distributor or sales representative.
Quantity in Commerce72 units
DistributionUS Nationwide distribution in the states of IL & LA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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