BEUDAMED
    FDA Enforcement Class II Terminated

    BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

    Recall: Z-0281-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0281-2019
    Event ID
    81036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    September 17, 2018
    Classification Date
    October 26, 2018
    Termination Date
    August 21, 2020
    Address
    1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States

    Description

    BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

    Reason

    The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.

    Code Info

    Zebra Printer Model TLP3842 - Affected PSU Part Number 808113-001 or P1028888-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week); Zebra Printer Model GX4301 - Affected PSU Part Number 808101-001 with date codes ranging from 0639XX through 1253XX (YYWWXX, where YY=year and WW=week).

    Distribution

    Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.

    Quantity

    876 devices (in U.S. and Canada)