BEUDAMED
    FDA Recall 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 · Initiated October 10, 2017

    Recall

    Recall Number
    Z-1361-2018
    Event Number
    79669
    Firm
    Crimson Trace Corporation
    FEI Number
    3000222719
    Product Code
    REU
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 10, 2017
    Posted
    April 23, 2018
    Terminated
    November 22, 2019
    Address
    9780 Sw Freeman Dr, Wilsonville, OR, 97070-9221

    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.

    Action

    Crimson Trace Corporation (CTC) will bring defect into compliance: 1.CTC will send notification letters or emails to all relevant dealers, distributors, and purchasers, 2.CTC will provide return merchandise authorization numbers and shipping labels to all relevant dealers, distributors, and purchasers, 3.CTC will replace all returned product units with compliant diodes, 4.The corrections will be conducted at no cost to the purchaser, and 5.The corrective action will be completed by January 31, 2019. For further questions, please call (800) 442-2406.

    Distribution

    USA (nationwide) Distribution

    Quantity

    184,390