Z-2964-2026 Class II Ongoing
FDA device recall Z-2964-2026 was initiated by AVID Medical, Inc. on July 10, 2026 and is designated Class II. Reason for recall: The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit. The recall status is ongoing. Affected quantity: 40 packs.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 packs
Product Description
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Reason for Recall
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Distribution Pattern
US Nationwide distribution in the state of TX.
Code Information
UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027