BEUDAMED
    FDA Recall Terminated

    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

    Recall: Z-1614-2018 · Initiated December 13, 2017

    Recall

    Recall Number
    Z-1614-2018
    Event Number
    80020
    Firm
    Ii Vi Incorporated
    FEI Number
    3004940116
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 13, 2017
    Terminated
    April 22, 2020
    Address
    375 Saxonburg Blvd, Saxonburg, PA, 16056-9430

    Description

    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

    Reason

    Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.

    Action

    Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.

    Distribution

    US Distribution to Oregon.

    Quantity

    323,972