BEUDAMED
    FDA Enforcement Class II Terminated

    Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

    Recall: Z-0149-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0149-2020
    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: 138029 Product Usage: electrosurgical accessory

    Reason

    The sterile barrier of some devices may have been affected

    Code Info

    Lot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29

    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

    464,040 eaches