BEUDAMED
    FDA Recall Terminated

    Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.

    Recall: Z-1339-2011 · Initiated December 23, 2010

    Recall

    Recall Number
    Z-1339-2011
    Event Number
    57792
    Firm
    Aspen Surgical Products, Inc.
    FEI Number
    3002750084
    Product Code
    HMR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 23, 2010
    Posted
    February 16, 2011
    Terminated
    October 7, 2011
    Address
    6945 Southbelt Dr Se, Caledonia, MI, 49316-7664

    Description

    Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.

    Reason

    Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.

    Action

    Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.

    Distribution

    Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.

    Quantity

    77850 all products