BEUDAMED
    FDA Recall Terminated

    EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470

    Recall: Z-0866-2010 · Initiated January 20, 2010

    Recall

    Recall Number
    Z-0866-2010
    Event Number
    54355
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DSY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 20, 2010
    Posted
    February 26, 2010
    Terminated
    July 6, 2010
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470

    Reason

    Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.

    Action

    Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.

    Distribution

    Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.

    Quantity

    18 units