FDA recall Z-1281-2022

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.

Key facts

Status

Ongoing

Initiation date

2022-04-26

Report date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1281-2022