Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit

FDA device recall Z-1741-2025 · posted 2025-05-09 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

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.

Action taken

An 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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

72 units

Distribution

US Nationwide distribution in the states of IL & LA.

Date initiated

2025-03-31

Date posted

2025-05-09

Location

Toano, VA