BEUDAMED
    FDA Recall Terminated

    Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.

    Recall: Z-1693-2009 · Initiated July 29, 2009

    Recall

    Recall Number
    Z-1693-2009
    Event Number
    52835
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    FMT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 29, 2009
    Posted
    August 26, 2009
    Terminated
    October 13, 2010
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.

    Reason

    Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

    Action

    Draeger Medical issued an Urgent Medical Device Recall letter via certified mail on 8/7/09. The letter explained the problem, the need to conduct an inspection of the infant warmer (instructions included), and request replacement elements.

    Distribution

    Worldwide distribution: USA, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica.

    Quantity

    2915 elements