BEUDAMED
    FDA Recall Terminated

    Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.

    Recall: Z-1815-2009 · Initiated March 31, 2009

    Recall

    Recall Number
    Z-1815-2009
    Event Number
    52523
    Firm
    Hospira Inc
    FEI Number
    2921482
    Product Code
    frn
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 31, 2009
    Posted
    August 11, 2009
    Terminated
    December 18, 2010
    Address
    755 Jarvis Dr, Morgan Hill, CA, 95037-2810

    Description

    Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.

    Reason

    Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.

    Action

    Hospira, Inc. issued an "Urgent: Device Field Correction" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades. For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100.

    Distribution

    Product was distributed to 59 consignees to all 50 States.