Recall Z-1741-2025 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
| Date | May 9, 2025 (initiated Mar 31, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 72 units |
| Distribution | US Nationwide distribution in the states of IL & LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.