Medical device recalls Moderate risk

Xodus Medical Inc recalls Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

Recall date
September 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0149-2020
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: 138029 Product Usage: electrosurgical accessory

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