BEUDAMED
    FDA Enforcement Class II Terminated

    LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology

    Recall: Z-2073-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2073-2014
    Event ID
    68674
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laser Peripherals LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 23, 2014
    Initiation Date
    June 20, 2014
    Classification Date
    July 17, 2014
    Termination Date
    October 22, 2014
    Address
    13355 10th Ave N, Suite 110, Plymouth, MN, 55441-5553, United States

    Description

    LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology

    Reason

    Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.

    Code Info

    E14128 & E14129

    Distribution

    Nationwide Distribution to IL, IN, and MD

    Quantity

    25