BEUDAMED
    FDA Recall Terminated

    Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT

    Recall: Z-0144-2008 · Initiated August 17, 2007

    Recall

    Recall Number
    Z-0144-2008
    Event Number
    44957
    Firm
    Karl Storz Endoscopy America Inc 600 Corporate Pointe
    FEI Number
    2020550
    Product Code
    HIG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 17, 2007
    Posted
    November 7, 2007
    Terminated
    February 29, 2012
    Address
    Culver City, CA, 90230-7600

    Description

    Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT

    Reason

    Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

    Action

    All affected customers were notified via a Customer Letter issued on September 10, 2007 via FedEx overnight mail. The letter describes the problem with the device and the health hazard risk, and provides instructions for users to return the old stand and make arrangements for replacement stands.

    Distribution

    Nationwide

    Quantity

    287