FDA recall Z-1338-2026
AVID Medical, Inc. · Class II · device
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Reason for recall
Tyvek bag seal issue which may compromise sterility of the kit.
Distribution
US Nationwide distribution in the states of New Jersey.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-01-02
- Report date
- 2026-02-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2026