BEUDAMED
    FDA Recall Terminated

    Maquet HLM Tubing Pack; Bioline Coating

    Recall: Z-2401-2010 · Initiated July 13, 2010

    Recall

    Recall Number
    Z-2401-2010
    Event Number
    56268
    Firm
    Maquet Inc.
    FEI Number
    3008355164
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 13, 2010
    Posted
    September 12, 2010
    Terminated
    August 10, 2011
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Maquet HLM Tubing Pack; Bioline Coating

    Reason

    The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.

    Action

    Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.

    Distribution

    Distribution: Pennsylvania

    Quantity

    5 units