FDA recall Z-0150-2020

Xodus Medical Inc · Class II · device

Product

Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory

Reason for recall

The sterile barrier of some devices may have been affected

Distribution

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico

Key facts

Status
Terminated
Initiation date
2019-09-19
Report date
2019-10-23
Termination date
2024-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Kensington, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2020