BEUDAMED
    FDA Recall 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 · Initiated June 20, 2014

    Recall

    Recall Number
    Z-2073-2014
    Event Number
    68674
    Firm
    Laser Peripherals LLC
    FEI Number
    1221543
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 20, 2014
    Posted
    July 17, 2014
    Terminated
    October 22, 2014
    Address
    13355 10th Ave N, Suite 110, Plymouth, MN, 55441-5553

    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'.

    Action

    Laser Peripherals contacted all consignees via telephone on June 20, 2014, in regard to the product being recalled by following the firm's Standard Operating Procedures. The SOP's included Instructions to immediately stop the use of the recalled product and provided other communications related to the recall. For questions regarding this recall call 612-280-1318.

    Distribution

    Nationwide Distribution to IL, IN, and MD

    Quantity

    25