BEUDAMED
    FDA Recall Terminated

    AEROSET Analyzer

    Recall: Z-0844-03 · Initiated August 15, 2002

    Recall

    Recall Number
    Z-0844-03
    Event Number
    25771
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2002
    Posted
    May 20, 2003
    Terminated
    April 7, 2004
    Address
    1921 Hurd Drive PO Box 2020, Irving, TX, 75038

    Description

    AEROSET Analyzer

    Reason

    Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.

    Action

    The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance.

    Distribution

    Nationwide and to the following foreign countries: Mexico, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, New Zealand, and China

    Quantity

    578