BEUDAMED
    FDA Recall Terminated

    Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

    Recall: Z-2652-2010 · Initiated July 27, 2010

    Recall

    Recall Number
    Z-2652-2010
    Event Number
    56481
    Firm
    Lumenis, Inc.
    FEI Number
    1720381
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 27, 2010
    Posted
    September 30, 2010
    Terminated
    October 5, 2010
    Address
    3959 W 1820 S, Salt Lake City, UT, 84104

    Description

    Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

    Reason

    Firm did not have proper 510(K) clearance.

    Action

    Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.

    Distribution

    FL, IL, MD, CO and TX

    Quantity

    250 probes (25 boxes, each containing 10 probes)