Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Recall
- Recall Number
- Z-1742-2025
- Event Number
- 96731
- Firm
- AVID Medical, Inc.
- FEI Number
- 1047429
- Product Code
- OEZ
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 31, 2025
- Posted
- May 9, 2025
- Address
- 9000 Westmont Dr, Toano, VA, 23168-9351
Description
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
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.
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.
US Nationwide distribution in the states of IL & LA.
60 units