BEUDAMED
    FDA Enforcement Class II Terminated

    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.

    Recall: Z-1361-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1361-2018
    Event ID
    79669
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Crimson Trace Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    October 10, 2017
    Classification Date
    April 23, 2018
    Termination Date
    November 22, 2019
    Address
    9780 Sw Freeman Dr, N/A, Wilsonville, OR, 97070-9221, United States

    Description

    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.

    Reason

    A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.

    Code Info

    Model No. CTC with Laser Sights.

    Distribution

    USA (nationwide) Distribution

    Quantity

    184,390