Xodus Medical Inc recalls Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory

Recall date

September 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0150-2020

FDA classification

Class II

Brand / firm

Xodus Medical Inc

Sold / distributed

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

Why it was recalled

The sterile barrier of some devices may have been affected

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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