BEUDAMED
    FDA Recall Terminated

    Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.

    Recall: Z-1955-2009 · Initiated July 17, 2009

    Recall

    Recall Number
    Z-1955-2009
    Event Number
    52718
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    FMT
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    July 17, 2009
    Posted
    August 25, 2009
    Terminated
    June 1, 2011
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.

    Reason

    Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.

    Action

    On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible.

    Distribution

    Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela.

    Quantity

    6489 units