Device recall
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
- Recall number
- Z-2964-2026
- Event id
- 99443
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Aug 26, 2026
- Initiated
- Jul 10, 2026
- Center classification date
- Aug 14, 2026
- Reason
- The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Quantity
- 40 packs
- Code info
- UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
- Distribution
- US Nationwide distribution in the state of TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States