BEUDAMED
    FDA Recall Terminated

    Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.

    Recall: Z-1224-06 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-1224-06
    Event Number
    35738
    Firm
    Medisurg Research & Management Corp
    FEI Number
    3003408230
    Product Code
    NCR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    August 2, 2006
    Terminated
    September 8, 2006
    Address
    100 W Fornance Street, The Fugo Building, Norristown, PA, 19401

    Description

    Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.

    Reason

    No documentation to support shelf life/sterility

    Action

    On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.

    Distribution

    Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.

    Quantity

    960 tips