Device recall
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
- Recall number
- Z-0102-2027
- 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
- LRO
- Device type
- General Surgery Tray
- Reason
- Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Root cause
- Process change control
- Quantity
- 96
- Code info
- Model/Item Number (Kit): MECV97W; UDI-DI: 10809160493113; Kit Lot Numbers: 1691836, 1696316; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): 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