BEUDAMED
    FDA Recall Terminated

    Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.

    Recall: Z-2063-2010 · Initiated May 24, 2010

    Recall

    Recall Number
    Z-2063-2010
    Event Number
    56004
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    MAL
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 24, 2010
    Posted
    July 22, 2010
    Terminated
    July 14, 2011
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.

    Reason

    Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

    Action

    Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.

    Distribution

    Nationwide Distribution.

    Quantity

    xx