Device recall
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
- Recall number
- Z-0283-2027
- Event id
- 99968
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Sep 8, 2026
- Center classification date
- Oct 22, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
- Root cause
- Process control
- Quantity
- 80 kits
- Code info
- Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827. Expiration Date: 1/31/2028.
- Distribution
- US Nationwide distributor in the state of Arizona.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States