BEUDAMED
    FDA Recall Terminated

    Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    Recall: Z-0147-2010 · Initiated August 11, 2009

    Recall

    Recall Number
    Z-0147-2010
    Event Number
    53257
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    dxg
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 11, 2009
    Posted
    November 9, 2009
    Terminated
    April 4, 2012

    Description

    Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    Reason

    Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

    Action

    Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.

    Distribution

    Worldwide distribution.

    Quantity

    204,999 power cords distributed for all devices