BEUDAMED
    FDA Recall Terminated

    Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.

    Recall: Z-0585-2008 · Initiated December 18, 2007

    Recall

    Recall Number
    Z-0585-2008
    Event Number
    46251
    Firm
    Lumenis, Inc.
    FEI Number
    1720381
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    December 18, 2007
    Posted
    April 9, 2008
    Terminated
    April 9, 2008
    Address
    3959 W 1820 S, Salt Lake City, UT, 84104-4951

    Description

    Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.

    Reason

    Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.

    Action

    The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355.

    Distribution

    MA

    Quantity

    59 units.