Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
AVID Medical, Inc. · 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…
Open FDA's page for this record- Cfres ID
- 213483
- Product res number
- Z-1742-2025
- Event date initiated
- 2025-03-31
- Event date posted
- 2025-05-09
- Recall status
- Open, Classified
- Res event number
- 96731
- Product code
- OEZ
- Product description
- Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
- Code info
- Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.
- Firm FEI number
- 1047429
- Recalling firm
- AVID Medical, Inc.
- Address 1
- 9000 Westmont Dr
- City
- Toano
- State
- VA
- Postal code
- 23168-9351
- Additional info contact
- Marlene Jones 757-566-3510
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 60 units
- Distribution pattern
- US Nationwide distribution in the states of IL & LA.
- 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
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.
- Harmonized identifiers (openFDA)
- Device name
- Cardiovascular Procedure Kit
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1200
- Device class
- 2
- Registration number
- 9680794, 3006950086, 3010155661, 1054241, 3004122598, 3002124543, 3014925393, 3007329020, 3004111573, 3013162291, 3032507796, 3004519921, 3011642792, 1423395, 3005595283, 1625425, 1125782, 1724474, 3015225571, 9616099, 3018077422, 3004911384, 1061124, 3005012805, 3012536737, 3015309643, 1928237, 1721676, 3009203853, 3024985933, 3009888344, 3015910259, 9616088, 1055236, 1043214, 3002807314, 3015053858, 3015173212, 1016427, 3017987980 +21 more
- FEI number
- 3006950086, 3010155661, 3001236905, 3004122598, 3002124543, 3014925393, 3007329020, 3004111573, 1000112968, 3013162291, 3000717925, 3032507796, 1000514656, 3002902735, 3011642792, 3005595283, 3003528016, 1625425, 3015225571, 3018077422, 3004911384, 3005012805, 1928237, 3012536737, 3015309643, 1721676, 3009203853, 3003094851, 3024985933, 1000123180, 3009888344, 3015910259, 1043214, 3005846326, 3002807314, 1000512168, 3015053858, 1016427, 3015173212, 1000138054 +21 more