Device recall
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
- Recall number
- Z-3194-2026
- Event id
- 99761
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- AVID Medical, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 23, 2026
- Initiated
- Jul 22, 2026
- Center classification date
- Sep 23, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
- Root cause
- Packaging process control
- Quantity
- 288 kits (6 cases)
- Code info
- Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States