BEUDAMED
    FDA Recall Terminated

    Equator Forced Air Convective Warming System, Reference Number EQ 5000

    Recall: Z-0497-05 · Initiated December 15, 2004

    Recall

    Recall Number
    Z-0497-05
    Event Number
    30703
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1221261
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2004
    Posted
    February 3, 2005
    Terminated
    June 27, 2006
    Address
    160 Weymouth St, Rockland, MA, 02370-1136

    Description

    Equator Forced Air Convective Warming System, Reference Number EQ 5000

    Reason

    Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

    Action

    Smiths Medical ASD notified customers by letter issued Fed''X on 12/15/04. Accounts are requested not to use the device and return the unit if the the unit has not yet been placed into service. If the unit has been placed into service and operated for more than one hour then the problem will not occur. EQ-5000 unit(s) will be replaced.

    Distribution

    Nationwide Foreign: Nederland BV, UK, Finland

    Quantity

    206 units