BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0281-2019 · Initiated September 17, 2018

    Recall

    Recall Number
    Z-0281-2019
    Event Number
    81036
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 17, 2018
    Terminated
    August 21, 2020
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    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.

    Action

    The recalling firm issued letters dated 9/3/2018 via email on 9/17/2018. A second letter dated 9/24/2018 was issued to update the acknowledgment form to include the number of affected power supply units the consignee destroyed.

    Distribution

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

    Quantity

    876 devices (in U.S. and Canada)