BEUDAMED
    FDA Recall Terminated

    Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

    Recall: Z-1593-2011 · Initiated December 7, 2010

    Recall

    Recall Number
    Z-1593-2011
    Event Number
    57519
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2010
    Posted
    March 7, 2011
    Terminated
    September 12, 2012
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

    Reason

    One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.

    Action

    The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.

    Distribution

    Nationwide distribution: SC only.

    Quantity

    one unit