BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0150-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0150-2020
    Event ID
    83819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xodus Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2019
    Initiation Date
    September 19, 2019
    Classification Date
    October 16, 2019
    Termination Date
    March 4, 2024
    Address
    702 Prominence Dr, N/A, New Kensington, PA, 15068-7052, United States

    Description

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

    Reason

    The sterile barrier of some devices may have been affected

    Code Info

    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

    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

    Quantity

    460,000 eaches