Z-0150-2020 Class II Terminated

Recalled by Xodus Medical Inc — New Kensington, PA

Recall Details

Product Type
Devices
Report Date
October 23, 2019
Initiation Date
September 19, 2019
Termination Date
March 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
460,000 eaches

Product Description

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 Pattern

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

Code Information

Lot # 16DEC19 17JAN06 17FEB10 17MAR27 17OCT09 17OCT09A 17OCT23 17OCT23A 18JAN05 18JAN05A 18JAN19 18MAR02 18MAR19 18MAR19A UDI: Case 20787551000584 and Each - 00787551000580 Additional lots as of 6/8/20: 18APR09 18MAY01 18MAY11 18MAY25 18MAY25A 18MAY25B 18JUN27 18AUG14 18SEP12 18OCT03 Additional lots as of 9/9/2021: 18DEC05 18DEC26 18DEC26A 19JAN30 19JAN30A