Device recall
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
- Recall number
- Z-3109-2026
- Event id
- 99525
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Sep 16, 2026
- Posted
- Sep 4, 2026
- Initiated
- Jul 14, 2026
- Center classification date
- Sep 4, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
- Root cause
- Packaging process control
- Quantity
- 98 Kits
- Code info
- Lot Number:1658438 7/31/2026 UDI: 10809160460481
- Distribution
- US Nationwide distribution in the state of NE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States