BEUDAMED
    FDA Recall Terminated

    Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.

    Recall: Z-1310-2010 · Initiated March 3, 2010

    Recall

    Recall Number
    Z-1310-2010
    Event Number
    54823
    Firm
    Aplicare, Inc.
    FEI Number
    1220701
    Product Code
    NAD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 3, 2010
    Posted
    April 8, 2010
    Terminated
    March 16, 2012
    Address
    550 Research Pkwy, Meriden, CT, 06450-7172

    Description

    Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.

    Reason

    Incorrect expiration date on outer kit label-extended.

    Action

    Aplicare notified customers by telephone on March 3, 2010 followed with "Product Recall Notice" letter issued by e-mail to the distributor level. Product will be labeled with correct expiration date. Direct questions to your sales representative or customer service by calling 1-800-760-3236.

    Distribution

    United States (CT, RI, NJ and OH).

    Quantity

    103 cases (20 each)