BEUDAMED
    FDA Recall Terminated

    ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC

    Recall: Z-0108-04 · Initiated October 8, 2003

    Recall

    Recall Number
    Z-0108-04
    Event Number
    27457
    Firm
    Anika Therapeutics
    FEI Number
    3007093114
    Product Code
    LZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2003
    Posted
    November 13, 2003
    Terminated
    August 9, 2004
    Address
    240 West Cummings Park, Woburn, MA, 01801

    Description

    ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC

    Reason

    Stability failure at the 20 month for viscosity specification

    Action

    Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.

    Distribution

    CA, MO, NC,VA

    Quantity

    10,100 units