BEUDAMED
    FDA Recall Terminated

    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

    Recall: Z-0361-2017 · Initiated March 16, 2011

    Recall

    Recall Number
    Z-0361-2017
    Event Number
    64005
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 16, 2011
    Terminated
    November 28, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

    Reason

    May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.

    Action

    Hospira sent an Urgent Device Recall Letters, dated February 5, 2013, to all affected customers. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form. Healthcare professionals were to contact Stericycle. Hospira discontinued support of these devices as of June 30, 2015. Customers with questions were instructed to call 1-800-201-9064. For questions regarding this recall call 224-212-4892.

    Distribution

    Worldwide Distribution - US (nationwide) and Canada

    Quantity

    10,337