FDA Enforcement
Class II
Ongoing
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Recall: Z-0386-2025
·
Reported November 20, 2024
Enforcement
- Recall Number
- Z-0386-2025
- Event ID
- 95515
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- AVID Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 20, 2024
- Initiation Date
- September 20, 2024
- Classification Date
- November 14, 2024
- Address
- 9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States
Description
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Reason
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
Code Info
GTIN: 10809160308288 Lot Number: 1591242, 1600320, 1604627
Distribution
US Nationwide distribution.
Quantity
100 eaches