BEUDAMED
    FDA Enforcement Class II Terminated

    Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

    Recall: Z-0151-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0151-2020
    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

    Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

    Reason

    The sterile barrier of some devices may have been affected

    Code Info

    Lot # 16DEC19 17JAN06 17JAN06A 17JAN23 17FEB27 17MAR13 17MAR13A 17APR03 17APR14 17MAY24 17MAY24A 17MAY24B 17JUN27 17JUL17 17AUG01 17SEP22 17SEP22A 17OCT23 17NOV27 17NOV27A 17DEC15 18JAN19 18JAN19A 18FEB16 18MAR02 18MAR19 18MAR19A ***Updated 11/9/21*** 19MAR14 UDI: Case 20787551000577 and Each 00787551000573

    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

    255,000 each