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-1383-05 · Initiated July 14, 2005

    Recall

    Recall Number
    Z-1383-05
    Event Number
    32711
    Firm
    Anika Therapeutics, Inc.
    FEI Number
    3007093114
    Product Code
    LZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2005
    Posted
    August 23, 2005
    Terminated
    May 2, 2006
    Address
    236 W Cummings Park, Woburn, MA, 01801-6346

    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

    Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

    Action

    Anika Therapeutics notified Distributor accounts by telephone on July 14. The letters were faxed and sent by Fedex on July 14. Distributors were provided with a end-user letter template letter for notification to their accounts.

    Distribution

    CA, NC

    Quantity

    3720 units