BEUDAMED
    FDA Recall Terminated

    SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.

    Recall: Z-1021-2010 · Initiated January 8, 2009

    Recall

    Recall Number
    Z-1021-2010
    Event Number
    54089
    Firm
    Hsmg, Inc. D/b/a Smartinfuser Usa
    FEI Number
    3004960040
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 8, 2009
    Posted
    March 8, 2010
    Terminated
    April 25, 2011
    Address
    8588 Katy Freeway, Suite 348, Houston, TX, 77024

    Description

    SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.

    Reason

    Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.

    Action

    SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.

    Distribution

    Nationwide.

    Quantity

    6,393 units