Device recall
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
- Recall number
- Z-0094-2027
- Event id
- 99808
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Oct 7, 2026
- Product code
- OEZ
- Device type
- Cardiovascular Procedure Kit
- Reason
- Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Root cause
- Process change control
- Quantity
- 59
- Code info
- 1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393;
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States