Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
Recall
- Recall Number
- Z-0446-2025
- Event Number
- 95515
- Firm
- AVID Medical, Inc.
- FEI Number
- 1047429
- Product Code
- OEZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 20, 2024
- Posted
- November 14, 2024
- Address
- 9000 Westmont Dr, Toano, VA, 23168-9351
Description
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take: If you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness. "Complete the attached Recall Response Form and return as soon as possible. Report any quality problems or adverse events associated with the products listed in this notification to [email protected].
US Nationwide distribution.
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