Device product
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Z-1281-2022
Product summary
- Event
- Event 90237
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 660 units
- Official record key
device-enforcement:Z-1281-2022
Official wording
Reason: Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250
Code information: UDI-DI: 30886158010488 Lot Number: 6045693
Distribution pattern: US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.
Derived failure modes
-
Unknown
Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250